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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81182

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 27, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE.

Z-0411-2019
Recall number
Z-0411-2019
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
4,207 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

Code information

Model Number, UDI Number, (Serial Number): 2097674-001-US, Not Applicable, (5470345-30); 2097674-001-US, Not Applicable, (5470345-31); 2097674-001-US, Not Applicable, (5470345-32); 1011-9000-000, Not Applicable, (ANAK00774); 1011-9000-000, Not Applicable, (ANAK00775); 1011-9000-000, Not Applicable, (ANAL01201); 1011-9000-000, Not Applicable, (ANAL01234); 1011-9000-000, Not Applicable, (ANAL01235); 1011-9000-000, Not Applicable, (ANAL01236); 1011-9000-000, Not Applicable, (ANAL01237); 1011-9000-000, Not Applicable, (ANAL01238); 1011-9000-000, Not Applicable, (ANAL01240); 1011-9000-000, Not Applicable, (ANAL01494); 1011-9000-000, Not Applicable, (ANAL01495); 1011-9000-000, Not Applicable, (ANAL01551); 1011-9000-000, Not Applicable, (ANAM01023); 1011-9000-000, Not Applicable, (ANAM01024); 1011-9000-000, Not Applicable, (ANAM01025); 1011-9000-000, Not Applicable, (ANAM01026); 1011-9000-000, Not Applicable, (ANAM01027); 1011-9000-000, Not Applicable, (ANAM01104); 1011-9000-000, Not Applicable, (ANAM01105); 1011-9000-000, Not Applicable, (ANAP00438); 1011-9000-000, Not Applicable, (ANAP00439); 1011-9000-000, Not Applicable, (ANAQ01188); 1011-9000-000, Not Applicable, (ANAR05264); 1011-9000-000, Not Applicable, (ANAR05265); 1011-9000-000, Not Applicable, (ANAR05610); 1011-9000-000, Not Applicable, (ANAR05611); 1011-9000-000, Not Applicable, (ANAS00202); 1011-9000-000, Not Applicable, (ANAS00203); 1011-9000-000, Not Applicable, (ANAS00204); 2097674-001-US, Not Applicable, (5479630-1); ANAK00798, Not Applicable (1011-9000-000); ANAK00799, Not Applicable (1011-9000-000); ANAK00803, Not Applicable (1011-9000-000); ANAK00807, Not Applicable (1011-9000-000); ANAK00814, Not Applicable (1011-9000-000); ANAK00839, Not Applicable (1011-9000-000); ANAK00864, Not Applicable (1011-9000-000); 5481223-1, Not Applicable (2097674-001-US); 5481223-10, Not Applicable (2097674-001-US); 5481223-11, Not Applicable (2097674-001-US); 5481223-12, Not Applicable (2097674-001-US); 5481223-2, Not Applicable (2097674-001-US); 5481223-3, Not Applicable (2097674-001-US); 5481223-4, Not Applicable (2097674-001-US); 5481223-5, Not Applicable (2097674-001-US); 5481223-6, Not Applicable (2097674-001-US); 5481223-7, Not Applicable (2097674-001-US); 5481223-8, Not Applicable (2097674-001-US); 5481223-9, Not Applicable (2097674-001-US); ANAP00712, Not Applicable (1011-9000-000); ANAP00713, Not Applicable (1011-9000-000); ANAP00714, Not Applicable (1011-9000-000); ANAN01125, Not Applicable (1011-9000-000); ANAN01138, Not Applicable (1011-9000-000); 4652664-1, Not Applicable (2097674-001-US); 4652664-10, Not Applicable (2097674-001-US); 4652664-11, Not Applicable (2097674-001-US); 4652664-12, Not Applicable (2097674-001-US); 4652664-13, Not Applicable (2097674-001-US); 4652664-2, Not Applicable (2097674-001-US); 4652664-3, Not Applicable (2097674-001-US); 4652664-4, Not Applicable (2097674-001-US); 4652664-5, Not Applicable (2097674-001-US); 4652664-6, Not Applicable (2097674-001-US); 4652664-7, Not Applicable (2097674-001-US); 4652664-8, Not Applicable (2097674-001-US); 4652664-9, Not Applicable (2097674-001-US); ANAK00156, Not Applicable (1011-9000-000); ANAK00157, Not Applicable (1011-9000-000); ANAK00158, Not Applicable (1011-9000-000); ANAK00159, Not Applicable (1011-9000-000); ANAK00511, Not Applicable (1011-9000-000); ANAK00512, Not Applicable (1011-9000-000); ANAK00513, Not Applicable (1011-9000-000); ANAK00514, Not Applicable (1011-9000-000); ANAN01051, Not Applicable (1011-9000-000); ANAN01052, Not Applicable (1011-9000-000); ANAP00545, Not Applicable (1011-9000-000); ANAP00546, Not Applicable (1011-9000-000); ANAP00708, Not Applicable (1011-9000-000); ANAL01400, Not Applicable (1011-9000-000); ANAL01401, Not Applicable (1011-9000-000); ANAM00449, Not Applicable (1011-9000-000); ANAM01089, Not Applicable (1011-9000-000); 5453450-1, Not Applicable (2097674-001); 5453450-2, Not Applicable (2097674-001); 5453450-3, Not Applicable (2097674-001); 5453450-4, Not Applicable (2097674-001); 5453450-5, Not Applicable (2097674-001); 5453450-6, Not Applicable (2097674-001); 5453450-7, Not Applicable (2097674-001); 5453450-8, Not Applicable (2097674-001); 5480532-1, Not Applicable (2097674-001); 5447751-1, Not Applicable (2097674-001); 5447751-10, Not Applicable (2097674-001); 5447751-11, Not Applicable (2097674-001); 5447751-12, Not Applicable (2097674-001); 5447751-13, Not Applicable (2097674-001); 5447751-14, Not Applicable (2097674-001); 5447751-15, Not Applicable (2097674-001); 5447751-16, Not Applicable (2097674-001); 5447751-17, Not Applicable (2097674-001); 5447751-18, Not Applicable (2097674-001); 5447751-19, Not Applicable (2097674-001); 5447751-2, Not Applicable (2097674-001); 5447751-20, Not Applicable (2097674-001); 5447751-21, Not Applicable (2097674-001); 5447751-22, Not Applicable (2097674-001); 5447751-23, Not Applicable (2097674-001); 5447751-24, Not Applicable (2097674-001); 5447751-3, Not Applicable (2097674-001); 5447751-4, Not Applicable (2097674-001); 5447751-5, Not Applicable (2097674-001); 5447751-6, Not Applicable (2097674-001); 5447751-7, Not Applicable (2097674-001); 5447751-8, Not Applicable (2097674-001); 5447751-9, Not Applicable (2097674-001); 5452649-1, Not Applicable (2097674-001); 5452649-2, Not Applicable (2097674-001); 5474323-1, Not Applicable (2097674-DE); ANAR05021, Not Applicable (1011-9000-000); 5473625-5, Not Applicable (2097674-NL); 5473625-6, Not Applicable (2097674-NL); 5473625-7, Not Applicable (2097674-NL); ANAK00330, Not Applicable (1011-9000-000); ANAK00332, Not Applicable (1011-9000-000); ANAK00334, Not Applicable (1011-9000-000); ANAL00806, Not Applicable (1011-9000-000); ANAL00807, Not Applicable (1011-9000-000); ANAL00808, Not Applicable (1011-9000-000); ANAL00809, Not Applicable (1011-9000-000); ANAN01010, Not Applicable (1011-9000-000); ANAN01011, Not Applicable (1011-9000-000); ANAN01012, Not Applicable (1011-9000-000); ANAN01013, Not Applicable (1011-9000-000); ANAN01014, Not Applicable (1011-9000-000); ANAP00399, Not Applicable (1011-9000-000); ANAP01133, Not Applicable (1011-9000-000); ANAR00344, Not Applicable (1011-9000-000); ANAR00896, Not Applicable (1011-9000-000); ANAR05978, Not Applicable (1011-9000-000); ANAR05979, Not Applicable (1011-9000-000); ANAR05980, Not Applicable (1011-9000-000); ANAR05981, Not Applicable (1011-9000-000); ANAR05982, Not Applicable (1011-9000-000); ANAR05983, Not Applicable (1011-9000-000); ANAR05984, Not Applicable (1011-9000-000); ANAS00709, Not Applicable (1011-9000-000); ANAS00710, Not Applicable (1011-9000-000); ANAS00711, Not Applicable (1011-9000-000); 5472401-2, Not Applicable (2097674-001); ANAP00132, Not Applicable (1011-9000-000); 5472557-4, Not Applicable (2097674-001); 5472557-5, Not Applicable (2097674-001); 5472557-6, Not Applicable (2097674-001); ANAN01045, Not Applicable (1011-9000-000); ANAN01046, Not Applicable (1011-9000-000); ANAR00327, Not Applicable (1011-9000-000); ANAS00345, Not Applicable (1011-9000-000); 5454764-3, Not Applicable (2097674-001); ANAP00584, Not Applicable (1011-9000-000); ANAP00585, Not Applicable (1011-9000-000); ANAP00586, Not Applicable (1011-9000-000); ANAP00587, Not Applicable (1011-9000-000); ANAP00588, Not Applicable (1011-9000-000); ANAP00589, Not Applicable (1011-9000-000); ANAP00825, Not Applicable (1011-9000-000); ANAP01215, Not Applicable (1011-9000-000); ANAS00738, Not Applicable (1011-9000-000); ANAL01390, Not Applicable (1011-9000-000); ANAL01391, Not Applicable (1011-9000-000); ANAS00391, Not Applicable (1011-9000-000); ANAR00492, Not Applicable (1011-9000-000); ANAR00493, Not Applicable (1011-9000-000); ANAR00494, Not Applicable (1011-9000-000); ANAR00495, Not Applicable (1011-9000-000); ANAR00496, Not Applicable (1011-9000-000); ANAR00497, Not Applicable (1011-9000-000); ANAR00498, Not Applicable (1011-9000-000); ANAR00499, Not Applicable (1011-9000-000); ANAR00500, Not Applicable (1011-9000-000); ANAR00501, Not Applicable (1011-9000-000); ANAR00756, Not Applicable (1011-9000-000); ANAR00757, Not Applicable (1011-9000-000); ANAL00705, Not Applicable (1011-9000-000); ANAL01040, Not Applicable (1011-9000-000); ANAL01041, Not Applicable (1011-9000-000); ANAL01042, Not Applicable (1011-9000-000); ANAL01043, Not Applicable (1011-9000-000); ANAL01044, Not Applicable (1011-9000-000); ANAL01045, Not Applicable (1011-9000-000); ANAL01046, Not Applicable (1011-9000-000); ANAL01047, Not Applicable (1011-9000-000); ANAL01048, Not Applicable (1011-9000-000); ANAL01050, Not Applicable (1011-9000-000); ANAM00335, Not Applicable (1011-9000-000); ANAL00192, Not Applicable (1011-9000-000); ANAL00754, Not Applicable (1011-9000-000); ANAL00755, Not Applicable (1011-9000-000); ANAL00756, Not Applicable (1011-9000-000); ANAL00757, Not Applicable (1011-9000-000); ANAL00764, Not Applicable (1011-9000-000); ANAL00769, Not Applicable (1011-9000-000); ANAL00776, Not Applicable (1011-9000-000); ANAL00777, Not Applicable (1011-9000-000); ANAL00778, Not Applicable (1011-9000-000); ANAL00779, Not Applicable (1011-9000-000); ANAL00780, Not Applicable (1011-9000-000); ANAL00781, Not Applicable (1011-9000-000); ANAL00782, Not Applicable (1011-9000-000); ANAL00783, Not Applicable (1011-9000-000); ANAL00784, Not Applicable (1011-9000-000); ANAL00785, Not Applicable (1011-9000-000); ANAL00786, Not Applicable (1011-9000-000); ANAL00787, Not Applicable (1011-9000-000); ANAL00788, Not Applicable (1011-9000-000); ANAL00789, Not Applicable (1011-9000-000); ANAL00790, Not Applicable (1011-9000-000); ANAL00791, Not Applicable (1011-9000-000); ANAL00792, Not Applicable (1011-9000-000); ANAL01541, Not Applicable (1011-9000-000); ANAL01542, Not Applicable (1011-9000-000); ANAP00810, Not Applicable (1011-9000-000); ANAP00811, Not Applicable (1011-9000-000); ANAS00938, Not Applicable (1011-9000-000); ANAP01070, Not Applicable (1011-9000-000); 5473409-1, Not Applicable (2097674-FR); 5473409-2, Not Applicable (2097674-FR); 5473409-3, Not Applicable (2097674-FR); ANAP00517, Not Applicable (1011-9000-000); ANAP00518, Not Applicable (1011-9000-000); ANAP00519, Not Applicable (1011-9000-000); ANAM01291, Not Applicable (1011-9000-000); ANAM01292, Not Applicable (1011-9000-000); ANAM01293, Not Applicable (1011-9000-000); ANAN00430, Not Applicable (1011-9000-000); ANAN00431, Not Applicable (1011-9000-000); ANAN00432, Not Applicable (1011-9000-000); ANAN00436, Not Applicable (1011-9000-000); ANAN00437, Not Applicable (1011-9000-000); ANAP00300, Not Applicable (1011-9000-000); ANAQ00766, Not Applicable (1011-9000-000); ANAS00753, Not Applicable (1011-9000-000); ANAP00492, Not Applicable (1011-9000-000); ANAP00493, Not Applicable (1011-9000-000); ANAM00628, Not Applicable (1011-9000-000); ANAL01029, Not Applicable (1011-9000-000); 5479515-1, Not Applicable (2097674-JA); 5479515-2, Not Applicable (2097674-JA); 5479515-3, Not Applicable (2097674-JA); 5479515-4, Not Applicable (2097674-JA); 5479515-5, Not Applicable (2097674-JA); 5479515-6, Not Applicable (2097674-JA); 5479515-7, Not Applicable (2097674-JA); 5479515-8, Not Applicable (2097674-JA); 5479515-9, Not Applicable (2097674-JA); 5480673-1, Not Applicable (2097674-JA); 5480673-2, Not Applicable (2097674-JA); 5480673-3, Not Applicable (2097674-JA); 5480673-4, Not Applicable (2097674-JA); 5480673-5, Not Applicable (2097674-JA); 5480673-6, Not Applicable (2097674-JA); 5480673-7, Not Applicable (2097674-JA); 5480673-8, Not Applicable (2097674-JA); 5483069-1, Not Applicable (2097674-JA); ANAQ01435, Not Applicable (1011-9000-000); ANAM01312, Not Applicable (1011-9000-000); ANAM01313, Not Applicable (1011-9000-000); ANAM01315, Not Applicable (1011-9000-000); ANAM01317, Not Applicable (1011-9000-000); ANAM01318, Not Applicable (1011-9000-000); ANAM01320, Not Applicable (1011-9000-000); ANAM01324, Not Applicable (1011-9000-000); ANAM01325, Not Applicable (1011-9000-000); ANAL01313, Not Applicable (1011-9000-000); ANAL01314, Not Applicable (1011-9000-000); ANAL01315, Not Applicable (1011-9000-000); ANAL01316, Not Applicable (1011-9000-000); ANAL01317, Not Applicable (1011-9000-000); ANAL01318, Not Applicable (1011-9000-000); ANAL01319, Not Applicable (1011-9000-000); ANAL01320, Not Applicable (1011-9000-000); ANAM01302, Not Applicable (1011-9000-000); ANAM01304, Not Applicable (1011-9000-000); ANAN00487, Not Applicable (1011-9000-000); ANAN00488, Not Applicable (1011-9000-000); ANAN00489, Not Applicable (1011-9000-000); ANAN00490, Not Applicable (1011-9000-000); ANAN00491, Not Applicable (1011-9000-000); ANAN00492, Not Applicable (1011-9000-000); ANAR05143, Not Applicable (1011-9000-000); ANAR05144, Not Applicable (1011-9000-000); 5450447-2, Not Applicable (2097674-NL); 5450447-4, Not Applicable (2097674-NL); 5454351-1, Not Applicable (2097674-NL); 5454351-2, Not Applicable (2097674-NL); ANAR00198, Not Applicable (1011-9000-000); ANAR00199, Not Applicable (1011-9000-000); ANAR00200, Not Applicable (1011-9000-000); ANAR00279, Not Applicable (1011-9000-000); ANAM01311, Not Applicable (1011-9000-000); ANAM01314, Not Applicable (1011-9000-000); ANAM01316, Not Applicable (1011-9000-000); ANAM01319, Not Applicable (1011-9000-000); ANAM01321, Not Applicable (1011-9000-000); ANAM01322, Not Applicable (1011-9000-000); ANAM01323, Not Applicable (1011-9000-000); 5456012-1, Not Applicable (2097674-001); 5456012-2, Not Applicable (2097674-001); 5456012-3, Not Applicable (2097674-001); 5456719-1, Not Applicable (2097674-001); ANAN01065, Not Applicable (1011-9000-000); ANAN01066, Not Applicable (1011-9000-000); 5476468-1, Not Applicable (2097674-001); 5476468-10, Not Applicable (2097674-001); 5476468-11, Not Applicable (2097674-001); 5476468-12, Not Applicable (2097674-001); 5476468-13, Not Applicable (2097674-001); 5476468-14, Not Applicable (2097674-001); 5476468-15, Not Applicable (2097674-001); 5476468-16, Not Applicable (2097674-001); 5476468-17, Not Applicable (2097674-001); 5476468-2, Not Applicable (2097674-001); 5476468-3, Not Applicable (2097674-001); 5476468-4, Not Applicable (2097674-001); 5476468-5, Not Applicable (2097674-001); 5476468-6, Not Applicable (2097674-001); 5476468-7, Not Applicable (2097674-001); 5476468-8, Not Applicable (2097674-001); 5476468-9, Not Applicable (2097674-001); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097674-001-US, Not Applicable, (APWV01271); 2097674-001-US, Not Applicable, (APWU01812); 2097674-001-US, Not Applicable, (ANAR00714); 2097674-001-US, Not Applicable, (ANAR00741); 2097674-001-US, Not Applicable, (ANAS00330); 2097674-001-US, Not Applicable, (ANAS01319); 2097674-001-US, Not Applicable, (ANAS01320); 2097674-001-US, Not Applicable, (APWU00486); 2097674-001-US, Not Applicable, (APWU00487); 2097674-001-US, Not Applicable, (APWU00575); 2097674-001-US, Not Applicable, (APWU01267); 2097674-001-US, Not Applicable, (APWX00154); 2097674-001-US, Not Applicable, (APWX00155); 2097674-001-US, Not Applicable, (APWX00156); 2097674-001-US, Not Applicable, (APWX00157); 1011-9000-000, Not Applicable, (ANAS00456); 2097674-001-US, Not Applicable, (ANAM00764); 2097674-001-US, Not Applicable, (ANAM00765); 2097674-001-US, Not Applicable, (ANAM00766); 2097674-001-US, Not Applicable, (ANAM00767); 2097674-001-US, Not Applicable, (ANAM00768); 2097674-001-US, Not Applicable, (ANAM00769); 2097674-001-US, Not Applicable, (ANAM00770); 2097674-001-US, Not Applicable, (ANAM00771); 2097674-001-US, Not Applicable, (ANAM00772); 2097674-001-US, Not Applicable, (ANAM00773); 2097674-001-US, Not Applicable, (ANAM00774); 2097674-001-US, Not Applicable, (ANAM00775); 2097674-001-US, Not Applicable, (APWV00946); 2097674-001, Not Applicable, (ANAL00264); 2097674-001, Not Applicable, (ANAL00265); 2097674-001, Not Applicable, (ANAL00266); 2097674-001, Not Applicable, (ANAK00415); 2097674-001, Not Applicable, (ANAK00703); 2097674-001, Not Applicable, (ANAK00705); 2097674-001, Not Applicable, (ANAK00707); 2097674-001, Not Applicable, (ANAK00709); 2097674-001, Not Applicable, (ANAK00410); 2097674-001, Not Applicable, (ANAK00411); 2097674-001, Not Applicable, (ANAK00413); 2097674-001, Not Applicable, (ANAK00414); 2097674-001, Not Applicable, (ANAK00416); 2097674-001, Not Applicable, (ANAK00417); 2097674-001, Not Applicable, (ANAK00421); 2097674-001, Not Applicable, (ANAL00893); 2097674-001, Not Applicable, (APWU02246); 2097674-001, Not Applicable, (APWV00404); 2097674-001, Not Applicable, (ANAK00412); 2097674-001, Not Applicable, (ANAK00418); 2097674-001, Not Applicable, (ANAK00419); 2097674-001, Not Applicable, (ANAK00420); 2097674-001, Not Applicable, (ANAK00704); 2097674-001, Not Applicable, (ANAK00706); 2097674-001, Not Applicable, (ANAK00708); 2097674-001, Not Applicable, (APWW00334); 1011-9000-000, Not Applicable, (ANAR05371); 2097674-DE, Not Applicable, (ANAS00870); 1011-9000-000, Not Applicable, (ANAR00333); 1011-9000-000, Not Applicable, (ANAJ00122); 1011-9000-000, Not Applicable, (ANAQ01270); 1011-9000-000, Not Applicable, (ANAQ01271); 1011-9000-000, Not Applicable, (ANAQ01272); 1011-9000-000, Not Applicable, (ANAQ01273); 1011-9000-000, Not Applicable, (ANAQ01274); 1011-9000-000, Not Applicable, (ANAQ01275); 1011-9000-000, Not Applicable, (ANAQ01276); 1011-9000-000, Not Applicable, (ANAQ01277); 1011-9000-000, Not Applicable, (ANAR00187); 1011-9000-000, Not Applicable, (ANAR00188); 1011-9000-000, Not Applicable, (ANAR00189); 1011-9000-000, Not Applicable, (ANAR00190); 1011-9000-000, Not Applicable, (ANAR00191); 1011-9000-000, Not Applicable, (ANAR00192); 1011-9000-000, Not Applicable, (ANAR00334); 1011-9000-000, Not Applicable, (ANAR00701); 1011-9000-000, Not Applicable, (APWU02039); 1011-9000-000, Not Applicable, (APWW01068); 2097674-001, Not Applicable, (ANAQ00825); 1011-9000-000, Not Applicable, (ANAR05370); 2097674-FR, Not Applicable, (ANAN01100); 1011-9000-000, Not Applicable, (ANAT00157); 1011-9000-000, Not Applicable, (ANAT00158); 1011-9000-000, Not Applicable, (ANAT00156); 1011-9000-000, Not Applicable, (ANAR05372);

Distribution pattern

Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

device · product 2 of 3

Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Z-0412-2019
Recall number
Z-0412-2019
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
4,207 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

Code information

Model Number, UDI Number, (Serial Number): 1011-9050-000, 010084068210229221APWX0132811180608, (APWX01328); 1011-9050-000, 010084068210229221APWX0048411180208, (APWX00484); 1011-9050-000, 010084068210229221APWW0214911171214, (APWW02149); 1011-9050-000, 10084068210229221APWW0215011171214, (APWW02150); 1011-9050-000, 010084068210229221APWX0026111180118, (APWX00261); 1011-9050-000, 010084068210229221APWX0026211180118, (APWX00262); 1011-9050-000, 010084068210229221APWX0140911180618, (APWX01409); 1011-9050-000, 010084068210229221APWX0141011180618, (APWX01410); 1011-9050-000, 010084068210229221APWX0141111180618, (APWX01411); 1011-9050-000, 010084068210229221APWX0141211180618, (APWX01412); 1011-9050-000, 010084068210229221APWX0141311180618, (APWX01413); 1011-9050-000, 010084068210229221APWX0141411180618, (APWX01414); 1011-9050-000, 010084068210229221APWX0141511180618, (APWX01415); 1011-9050-000, 010084068210229221APWX0141611180618, (APWX01416); 1011-9050-000, 010084068210229221APWX0141711180618, (APWX01417); 1011-9050-000, 010084068210229221APWX0141811180618, (APWX01418); 1011-9050-000, 010084068210229221APWX0141911180618, (APWX01419); 1011-9050-000, 010084068210229221APWX0142011180618, (APWX01420); 1011-9050-000, 010084068210229221APWX0142111180618, (APWX01421); 1011-9050-000, 010084068210229221APWX0142211180618, (APWX01422); 1011-9050-000, 010084068210229221APWX0026311180118, (APWX00263); 1011-9050-000, 010084068210229221APWX0026411180118, (APWX00264); 1011-9050-000, 010084068210229221APWX0026511180118, (APWX00265); 1011-9050-000, 010084068210229221APWW0214011171214, (APWW02140); 1011-9050-000, 010084068210229221APWW0215611171214, (APWW02156); 1011-9050-000, 010084068210229221APWW0215711171214, (APWW02157); 1011-9050-000, 010084068210229221APWX0158911180703, (APWX01589); 1011-9050-000, 010084068210229221APWX0159011180703, (APWX01590); 1011-9050-000, 010084068210229221APWX0159111180703, (APWX01591); 1011-9050-000, 010084068210229221APWX0159211180703, (APWX01592); 1011-9050-000, 010084068210229221APWX0159311180703, (APWX01593); 1011-9050-000, 010084068210229221APWX0159411180703, (APWX01594); 1011-9050-000, 010084068210229221APWW0146411170823, (APWW01464); 1011-9050-000, 10084068210229221APWW0162511170927, (APWW01625); 1011-9050-000, 10084068210229221APWW0162611170927, (APWW01626); 1011-9050-000, 10084068210229221APWW0162811170927, (APWW01628); 1011-9050-000, 10084068210229221APWW0208811171206, (APWW02088); 1011-9050-000, 10084068210229221APWW0208911171206, (APWW02089); 1011-9050-000, 10084068210229221APWW0209011171206, (APWW02090); 1011-9050-000, 10084068210229221APWW0209111171212, (APWW02091); 1011-9050-000, 10084068210229221APWW0209211171212, (APWW02092); 1011-9050-000, 10084068210229221APWW0209311171212, (APWW02093); 1011-9050-000, 10084068210229221APWW0209411171212, (APWW02094); 1011-9050-000, 10084068210229221APWW0209511171212, (APWW02095); 1011-9050-000, 10084068210229221APWW0209611171212, (APWW02096); 1011-9050-000, 10084068210229221APWW0209711171212, (APWW02097); 1011-9050-000, 10084068210229221APWW0209811171212, (APWW02098); 1011-9050-000, 10084068210229221APWW0209911171212, (APWW02099); 1011-9050-000, 10084068210229221APWW0210011171212, (APWW02100); 1011-9050-000, 10084068210229221APWW0210111171212, (APWW02101); 1011-9050-000, 10084068210229221APWW0210211171212, (APWW02102); 1011-9050-000, 10084068210229221APWW0210311171212, (APWW02103); 1011-9050-000, 010084068210229221APWX0086711180328, (APWX00867); 1011-9050-000, 010084068210229221APWX0086811180328, (APWX00868); 1011-9050-000, 010084068210229221APWX0086911180328, (APWX00869); 1011-9050-000, 010084068210229221APWX0087011180328, (APWX00870); 1011-9050-000, 010084068210229221APWX0087111180328, (APWX00871); 1011-9050-000, 010084068210229221APWX0087211180328, (APWX00872); 1011-9050-000, 010084068210229221APWX0036911180131, (APWX00369); 1011-9050-000, 010084068210229221APWX0143411180618, (APWX01434); 1011-9050-000, 010084068210229221APWX0143511180618, (APWX01435); 1011-9050-000, 010084068210229221APWX0105311180427, (APWX01053); 1011-9050-000, 010084068210229221APWX0165911180716, (APWX01659); 1011-9050-000, 010084068210229221APWX0166011180716, (APWX01660); 1011-9050-000, 010084068210229221APWX0166111180716, (APWX01661); 1011-9050-000, 010084068210229221APWX0166211180716, (APWX01662); 1011-9050-000, 010084068210229221APWX0166311180716, (APWX01663); 1011-9050-000, 010084068210229221APWX0166411180716, (APWX01664); 1011-9050-000, 010084068210229221APWX0166511180716, (APWX01665); 1011-9050-000, 010084068210229221APWX0166611180716, (APWX01666); 2097675-001-US, Not Applicable, (4651698-2); 2097675-001-US, Not Applicable, (4666280-1); 2097675-001-US, Not Applicable, (4666282-1); 2097675-001-US, Not Applicable, (4666283-1); 2097675-001-US, Not Applicable, (4666288-1); 2097675-001-US, Not Applicable, (4666291-1); 2097675-001-US, Not Applicable, (4666300-1); 2097675-001-US, Not Applicable, (4666308-1); 2097675-001-US, Not Applicable, (4666314-1); 2097675-001-US, Not Applicable, (4666324-1); 2097675-001-US, Not Applicable, (4666335-1); 2097675-001-US, Not Applicable, (4666567-1); 1011-9050-000, 010084068210229221APWX0067511180315, (APWX00675); 1011-9050-000, 010084068210229221APWX0102611180417, (APWX01026); 1011-9050-000, 010084068210229221APWW0221511171219, (APWW02215); 1011-9050-000, 10084068210229221APWW0221611171219, (APWW02216); 1011-9050-000, 10084068210229221APWW0221711171219, (APWW02217); 1011-9050-000, 10084068210229221APWW0221811171219, (APWW02218); 1011-9050-000, 10084068210229221APWW0221911171219, (APWW02219); 1011-9050-000, 10084068210229221APWW0222011171219, (APWW02220); 1011-9050-000, 10084068210229221APWW0222111171219, (APWW02221); 1011-9050-000, 10084068210229221APWW0222211171219, (APWW02222); 1011-9050-000, 10084068210229221APWW0222311171219, (APWW02223); 1011-9050-000, 10084068210229221APWW0222411171219, (APWW02224); 1011-9050-000, 10084068210229221APWW0222511171219, (APWW02225); 1011-9050-000, 10084068210229221APWW0222611171219, (APWW02226); 1011-9050-000, 10084068210229221APWW0222711171219, (APWW02227); 1011-9050-000, 10084068210229221APWW0222811171219, (APWW02228); 1011-9050-000, 10084068210229221APWW0222911171219, (APWW02229); 1011-9050-000, 10084068210229221APWW0223011171219, (APWW02230); 1011-9050-000, 010084068210229221APWX0112211180507, (APWX01122); 1011-9050-000, 010084068210229221APWX0155711180627, (APWX01557); 1011-9050-000, 010084068210229221APWX0014411180105, (APWX00144); 1011-9050-000, 010084068210229221APWW0215111171214, (APWW02151); 1011-9050-000, 010084068210229221APWX0043411180206, (APWX00434); 1011-9050-000, 010084068210229221APWX0038711180201, (APWX00387); 1011-9050-000, 010084068210229221APWX0038811180201, (APWX00388); 1011-9050-000, 010084068210229221APWX0038911180201, (APWX00389); 1011-9050-000, 010084068210229221APWX0039011180201, (APWX00390); 1011-9050-000, 010084068210229221APWX0039111180201, (APWX00391); 1011-9050-000, 010084068210229221APWX0039211180201, (APWX00392); 1011-9050-000, 010084068210229221APWX0039311180201, (APWX00393); 1011-9050-000, 010084068210229221APWW0212811171212, (APWW02128); 1011-9050-000, 010084068210229221APWW0212911171212, (APWW02129); 1011-9050-000, 010084068210229221APWW0213011171212, (APWW02130); 1011-9050-000, 10084068210229221APWW0213111171214, (APWW02131); 1011-9050-000, 10084068210229221APWW0213211171214, (APWW02132); 1011-9050-000, 10084068210229221APWW0213311171214, (APWW02133); 1011-9050-000, 010084068210229221APWW0213411171214, (APWW02134); 1011-9050-000, 010084068210229221APWW0213511171214, (APWW02135); 1011-9050-000, 010084068210229221APWW0213611171214, (APWW02136); 1011-9050-000, 010084068210229221APWX0104411180427, (APWX01044); 1011-9050-000, 010084068210229221APWX0078811180323, (APWX00788); 1011-9050-000, 010084068210229221APWX0078911180323, (APWX00789); 1011-9050-000, 010084068210229221APWX0079011180323, (APWX00790); 1011-9050-000, 010084068210229221APWX0079111180328, (APWX00791); 1011-9050-000, 010084068210229221APWX0079211180328, (APWX00792); 1011-9050-000, 010084068210229221APWX0079311180328, (APWX00793); 1011-9050-000, 010084068210229221APWX0079411180328, (APWX00794); 1011-9050-000, 010084068210229221APWX0079511180328, (APWX00795); 1011-9050-000, 010084068210229221APWX0079611180328, (APWX00796); 1011-9050-000, 010084068210229221APWX0079711180328, (APWX00797); 1011-9050-000, 010084068210229221APWX0079811180328, (APWX00798); 1011-9050-000, 010084068210229221APWX0079911180328, (APWX00799); 1011-9050-000, 010084068210229221APWX0080011180328, (APWX00800); 1011-9050-000, 010084068210229221APWX0080111180328, (APWX00801); 1011-9050-000, 010084068210229221APWX0080211180328, (APWX00802); 1011-9050-000, 010084068210229221APWX0080311180328, (APWX00803); 1011-9050-000, 010084068210229221APWX0080411180328, (APWX00804); 1011-9050-000, 010084068210229221APWX0080511180328, (APWX00805); 1011-9050-000, 010084068210229221APWX0080611180328, (APWX00806); 1011-9050-000, 010084068210229221APWX0080711180328, (APWX00807); 1011-9050-000, 010084068210229221APWX0080811180328, (APWX00808); 1011-9050-000, 010084068210229221APWX0080911180328, (APWX00809); 1011-9050-000, 010084068210229221APWX0162811180711, (APWX01628); 1011-9050-000, 010084068210229221APWX0021611180115, (APWX00216); 1011-9050-000, 010084068210229221APWX0132311180608, (APWX01323); 1011-9050-000, 010084068210229221APWX0132411180608, (APWX01324); 1011-9050-000, 010084068210229221APWW0137311170802, (APWW01373); 1011-9050-000, 010084068210229221APWX0064811180309, (APWX00648); 1011-9050-000, 010084068210229221APWX0106011180427, (APWX01060); 1011-9050-000, 010084068210229221APWX0106111180427, (APWX01061); 1011-9050-000, 010084068210229221APWX0106211180427, (APWX01062); 1011-9050-000, 010084068210229221APWX0106311180427, (APWX01063); 1011-9050-000, 010084068210229221APWW0214111171214, (APWW02141); 1011-9050-000, 010084068210229221APWW0223111171219, (APWW02231); 1011-9050-000, 010084068210229221APWX0066111180309, (APWX00661); 1011-9050-000, 010084068210229221APWX0066211180309, (APWX00662); 1011-9050-000, 010084068210229221APWX0066311180309, (APWX00663); 1011-9050-000, 010084068210229221APWX0066411180309, (APWX00664); 1011-9050-000, 010084068210229221APWX0066511180309, (APWX00665); 1011-9050-000, 010084068210229221APWX0066611180309, (APWX00666); 1011-9050-000, 010084068210229221APWX0066711180309, (APWX00667); 1011-9050-000, 010084068210229221APWX0066811180309, (APWX00668); 1011-9050-000, 010084068210229221APWX0066911180309, (APWX00669); 1011-9050-000, 010084068210229221APWX0067011180309, (APWX00670); 1011-9050-000, 010084068210229221APWX0067111180315, (APWX00671); 1011-9050-000, 010084068210229221APWX0067211180315, (APWX00672); 1011-9050-000, 010084068210229221APWX0067311180315, (APWX00673); 1011-9050-000, 010084068210229221APWX0067611180315, (APWX00676); 1011-9050-000, 010084068210229221APWX0067711180315, (APWX00677); 1011-9050-000, 010084068210229221APWX0067811180315, (APWX00678); 1011-9050-000, 010084068210229221APWX0067911180315, (APWX00679); 1011-9050-000, 010084068210229221APWX0068011180315, (APWX00680); 1011-9050-000, 010084068210229221APWX0068111180315, (APWX00681); 1011-9050-000, 010084068210229221APWX0068211180315, (APWX00682); 1011-9050-000, 010084068210229221APWX0068311180315, (APWX00683); 1011-9050-000, 010084068210229221APWX0068411180315, (APWX00684); 1011-9050-000, 010084068210229221APWX0068511180315, (APWX00685); 1011-9050-000, 010084068210229221APWX0068611180315, (APWX00686); 1011-9050-000, 010084068210229221APWX0068711180315, (APWX00687); 1011-9050-000, 010084068210229221APWX0069111180315, (APWX00691); 1011-9050-000, 010084068210229221APWX0069211180315, (APWX00692); 1011-9050-000, 010084068210229221APWX0069311180315, (APWX00693); 1011-9050-000, 010084068210229221APWX0069411180315, (APWX00694); 1011-9050-000, 010084068210229221APWX0069511180315, (APWX00695); 1011-9050-000, 010084068210229221APWX0069611180315, (APWX00696); 1011-9050-000, 010084068210229221APWX0069711180315, (APWX00697); 1011-9050-000, 010084068210229221APWX0069811180315, (APWX00698); 1011-9050-000, 010084068210229221APWX0069911180315, (APWX00699); 1011-9050-000, 010084068210229221APWX0070011180315, (APWX00700); 1011-9050-000, 010084068210229221APWX0070111180315, (APWX00701); 1011-9050-000, 010084068210229221APWX0070211180315, (APWX00702); 1011-9050-000, 010084068210229221APWX0070311180315, (APWX00703); 1011-9050-000, 010084068210229221APWX0070411180315, (APWX00704); 1011-9050-000, 010084068210229221APWX0070511180315, (APWX00705); 1011-9050-000, 010084068210229221APWX0070611180315, (APWX00706); 1011-9050-000, 010084068210229221APWX0070711180315, (APWX00707); 1011-9050-000, 010084068210229221APWX0070811180315, (APWX00708); 1011-9050-000, 010084068210229221APWX0070911180315, (APWX00709); 1011-9050-000, 010084068210229221APWX0071011180315, (APWX00710); 1011-9050-000, 010084068210229221APWX0071311180319, (APWX00713); 1011-9050-000, 010084068210229221APWX0071411180319, (APWX00714); 1011-9050-000, 010084068210229221APWX0071511180319, (APWX00715); 1011-9050-000, 010084068210229221APWX0071611180319, (APWX00716); 1011-9050-000, 010084068210229221APWX0071711180319, (APWX00717); 1011-9050-000, 010084068210229221APWX0071811180319, (APWX00718); 1011-9050-000, 010084068210229221APWX0071911180319, (APWX00719); 1011-9050-000, 010084068210229221APWX0072011180319, (APWX00720); 1011-9050-000, 010084068210229221APWX0072111180319, (APWX00721); 1011-9050-000, 010084068210229221APWX0072211180319, (APWX00722); 1011-9050-000, 010084068210229221APWX0072311180319, (APWX00723); 1011-9050-000, 010084068210229221APWX0072411180319, (APWX00724); 1011-9050-000, 010084068210229221APWX0075111180323, (APWX00751); 1011-9050-000, 010084068210229221APWX0075211180323, (APWX00752); 1011-9050-000, 010084068210229221APWX0075311180323, (APWX00753); 1011-9050-000, 010084068210229221APWX0075411180323, (APWX00754); 1011-9050-000, 010084068210229221APWX0075511180323, (APWX00755); 1011-9050-000, 010084068210229221APWX0075611180323, (APWX00756); 1011-9050-000, 010084068210229221APWX0075711180323, (APWX00757); 1011-9050-000, 010084068210229221APWX0075811180323, (APWX00758); 1011-9050-000, 010084068210229221APWX0075911180323, (APWX00759); 1011-9050-000, 010084068210229221APWX0076011180323, (APWX00760); 1011-9050-000, 010084068210229221APWX0076111180323, (APWX00761); 1011-9050-000, 010084068210229221APWX0076211180323, (APWX00762); 1011-9050-000, 010084068210229221APWX0076311180323, (APWX00763); 1011-9050-000, 010084068210229221APWX0112111180507, (APWX01121); 1011-9050-000, 010084068210229221APWX0052911180222, (APWX00529); 1011-9050-000, 010084068210229221APWX0063411180309, (APWX00634); 1011-9050-000, 010084068210229221APWX0063511180309, (APWX00635); 1011-9050-000, 010084068210229221APWX0063611180309, (APWX00636); 1011-9050-000, 010084068210229221APWX0063711180309, (APWX00637); 1011-9050-000, 010084068210229221APWX0063811180309, (APWX00638); 1011-9050-000, 010084068210229221APWX0063911180309, (APWX00639); 1011-9050-000, 010084068210229221APWX0064011180309, (APWX00640); 1011-9050-000, 010084068210229221APWX0064111180309, (APWX00641); 1011-9050-000, 010084068210229221APWX0064211180309, (APWX00642); 1011-9050-000, 010084068210229221APWX0064311180309, (APWX00643); 1011-9050-000, 010084068210229221APWX0088111180328, (APWX00881); 1011-9050-000, 010084068210229221APWX0088211180328, (APWX00882); 1011-9050-000, 010084068210229221APWX0088311180328, (APWX00883); 1011-9050-000, 010084068210229221APWX0088411180328, (APWX00884); 1011-9050-000, 010084068210229221APWX0088511180328, (APWX00885); 1011-9050-000, 010084068210229221APWX0088611180328, (APWX00886); 1011-9050-000, 010084068210229221APWX0088711180328, (APWX00887); 1011-9050-000, 010084068210229221APWX0088811180328, (APWX00888); 1011-9050-000, 010084068210229221APWX0088911180328, (APWX00889); 1011-9050-000, 010084068210229221APWX0089011180328, (APWX00890); 1011-9050-000, 010084068210229221APWX0101311180417, (APWX01013); 1011-9050-000, 010084068210229221APWX0101411180417, (APWX01014); 1011-9050-000, 010084068210229221APWX0101511180417, (APWX01015); 1011-9050-000, 010084068210229221APWX0101611180417, (APWX01016); 1011-9050-000, 010084068210229221APWX0101711180417, (APWX01017); 1011-9050-000, 010084068210229221APWX0101811180417, (APWX01018); 1011-9050-000, 010084068210229221APWW0214211171214, (APWW02142); 1011-9050-000, 010084068210229221APWW0214311171214, (APWW02143); 1011-9050-000, 010084068210229221APWW0214411171214, (APWW02144); 1011-9050-000, 010084068210229221APWW0216411171214, (APWW02164); 1011-9050-000, 010084068210229221APWW0216511171214, (APWW02165); 1011-9050-000, 010084068210229221APWW0216611171214, (APWW02166); 1011-9050-000, 010084068210229221APWW0216711171214, (APWW02167); 1011-9050-000, 010084068210229221APWW0216811171214, (APWW02168); 1011-9050-000, 010084068210229221APWW0216911171214, (APWW02169); 1011-9050-000, 010084068210229221APWW0217011171214, (APWW02170); 1011-9050-000, 010084068210229221APWW0217111171218, (APWW02171); 1011-9050-000, 010084068210229221APWW0217211171218, (APWW02172); 1011-9050-000, 010084068210229221APWW0217311171218, (APWW02173); 1011-9050-000, 010084068210229221APWW0217411171218, (APWW02174); 1011-9050-000, 010084068210229221APWW0217511171218, (APWW02175); 1011-9050-000, 010084068210229221APWW0217611171218, (APWW02176); 1011-9050-000, 010084068210229221APWW0217711171218, (APWW02177); 1011-9050-000, 010084068210229221APWW0217811171218, (APWW02178); 1011-9050-000, 010084068210229221APWW0217911171218, (APWW02179); 1011-9050-000, 010084068210229221APWW0218011171218, (APWW02180); 1011-9050-000, 010084068210229221APWW0218111171218, (APWW02181); 1011-9050-000, 010084068210229221APWW0218211171218, (APWW02182); 1011-9050-000, 010084068210229221APWW0218311171218, (APWW02183); 1011-9050-000, 010084068210229221APWW0218411171218, (APWW02184); 1011-9050-000, 010084068210229221APWW0218511171218, (APWW02185); 1011-9050-000, 010084068210229221APWW0218611171218, (APWW02186); 1011-9050-000, 010084068210229221APWW0218711171218, (APWW02187); 1011-9050-000, 010084068210229221APWW0218811171218, (APWW02188); 1011-9050-000, 010084068210229221APWW0218911171218, (APWW02189); 1011-9050-000, 010084068210229221APWW0219011171218, (APWW02190); 1011-9050-000, 010084068210229221APWW0219111171218, (APWW02191); 1011-9050-000, 010084068210229221APWW0219211171218, (APWW02192); 1011-9050-000, 010084068210229221APWW0219311171218, (APWW02193); 1011-9050-000, 010084068210229221APWW0219411171218, (APWW02194); 1011-9050-000, 010084068210229221APWW0219511171218, (APWW02195); 1011-9050-000, 010084068210229221APWW0219611171218, (APWW02196); 1011-9050-000, 010084068210229221APWW0219711171218, (APWW02197); 1011-9050-000, 010084068210229221APWW0219811171218, (APWW02198); 1011-9050-000, 010084068210229221APWW0219911171218, (APWW02199); 1011-9050-000, 010084068210229221APWW0220011171218, (APWW02200); 1011-9050-000, 010084068210229221APWW0220111171218, (APWW02201); 1011-9050-000, 010084068210229221APWW0220211171218, (APWW02202); 1011-9050-000, 010084068210229221APWX0043711180206, (APWX00437); 1011-9050-000, 010084068210229221APWX0043811180206, (APWX00438); 1011-9050-000, 010084068210229221APWX0043911180206, (APWX00439); 1011-9050-000, 010084068210229221APWX0044011180206, (APWX00440); 1011-9050-000, 010084068210229221APWX0044111180206, (APWX00441); 1011-9050-000, 010084068210229221APWX0044211180206, (APWX00442); 1011-9050-000, 010084068210229221APWX0045211180206, (APWX00452); 1011-9050-000, 010084068210229221APWX0045311180206, (APWX00453); 1011-9050-000, 010084068210229221APWX0094211180410, (APWX00942); 1011-9050-000, 010084068210229221APWX0094311180410, (APWX00943); 1011-9050-000, 010084068210229221APWX0094411180410, (APWX00944); 1011-9050-000, 010084068210229221APWX0094511180410, (APWX00945); 1011-9050-000, 010084068210229221APWX0094611180410, (APWX00946); 1011-9050-000, 010084068210229221APWX0094711180410, (APWX00947); 1011-9050-000, 010084068210229221APWX0127911180604, (APWX01279); 1011-9050-000, 010084068210229221APWX0128011180604, (APWX01280); 1011-9050-000, 010084068210229221APWX0128111180604, (APWX01281); 1011-9050-000, 010084068210229221APWX0128211180604, (APWX01282); 1011-9050-000, 010084068210229221APWX0128311180604, (APWX01283); 1011-9050-000, 010084068210229221APWX0128411180604, (APWX01284); 1011-9050-000, 010084068210229221APWX0128511180604, (APWX01285); 1011-9050-000, 010084068210229221APWX0128611180604, (APWX01286); 1011-9050-000, 010084068210229221APWX0128711180604, (APWX01287); 1011-9050-000, 010084068210229221APWX0128811180604, (APWX01288); 1011-9050-000, 010084068210229221APWX0128911180604, (APWX01289); 1011-9050-000, 010084068210229221APWX0129011180604, (APWX01290); 1011-9050-000, 010084068210229221APWX0129111180604, (APWX01291); 1011-9050-000, 010084068210229221APWX0129211180604, (APWX01292); 1011-9050-000, 010084068210229221APWX0129311180604, (APWX01293); 1011-9050-000, 010084068210229221APWX0129411180604, (APWX01294); 1011-9050-000, 010084068210229221APWX0129511180604, (APWX01295); 1011-9050-000, 010084068210229221APWX0129611180604, (APWX01296); 1011-9050-000, 010084068210229221APWX0129711180604, (APWX01297); 1011-9050-000, 010084068210229221APWX0129811180604, (APWX01298); 1011-9050-000, 010084068210229221APWX0129911180604, (APWX01299); 1011-9050-000, 010084068210229221APWX0130011180604, (APWX01300); 1011-9050-000, 010084068210229221APWX0130111180608, (APWX01301); 1011-9050-000, 010084068210229221APWX0130211180608, (APWX01302); 1011-9050-000, 010084068210229221APWX0130311180608, (APWX01303); 1011-9050-000, 010084068210229221APWX0130411180608, (APWX01304); 1011-9050-000, 010084068210229221APWX0130511180608, (APWX01305); 1011-9050-000, 010084068210229221APWX0130611180608, (APWX01306); 1011-9050-000, 010084068210229221APWX0130711180608, (APWX01307); 1011-9050-000, 010084068210229221APWX0130811180608, (APWX01308); 1011-9050-000, 010084068210229221APWX0130911180608, (APWX01309); 1011-9050-000, 010084068210229221APWX0131011180608, (APWX01310); 1011-9050-000, 010084068210229221APWX0131111180608, (APWX01311); 1011-9050-000, 010084068210229221APWX0131211180608, (APWX01312); 1011-9050-000, 010084068210229221APWX0131311180608, (APWX01313); 1011-9050-000, 010084068210229221APWX0131411180608, (APWX01314); 1011-9050-000, 010084068210229221APWX0131511180608, (APWX01315); 1011-9050-000, 010084068210229221APWX0131611180608, (APWX01316); 1011-9050-000, 010084068210229221APWX0131711180608, (APWX01317); 1011-9050-000, 010084068210229221APWX0131811180608, (APWX01318); 1011-9050-000, 010084068210229221APWX0131911180608, (APWX01319); 1011-9050-000, 010084068210229221APWX0140311180618, (APWX01403); 1011-9050-000, 010084068210229221APWX0140411180618, (APWX01404); 1011-9050-000, 010084068210229221APWX0176811180720, (APWX01768); 1011-9050-000, 010084068210229221APWX0043511180206, (APWX00435); 1011-9050-000, 010084068210229221APWX0043611180206, (APWX00436); 1011-9050-000, 010084068210229221APWX0154511180627, (APWX01545); 1011-9050-000, 010084068210229221APWX0154611180627, (APWX01546); 1011-9050-000, 010084068210229221APWX0154711180627, (APWX01547); 1011-9050-000, 010084068210229221APWX0154811180627, (APWX01548); 1011-9050-000, 010084068210229221APWX0154911180627, (APWX01549); 1011-9050-000, 010084068210229221APWX0155011180627, (APWX01550); 1011-9050-000, 010084068210229221APWX0035311180131, (APWX00353); 1011-9050-000, 010084068210229221APWX0035411180131, (APWX00354); 1011-9050-000, 010084068210229221APWX0035511180131, (APWX00355); 1011-9050-000, 010084068210229221APWX0035611180131, (APWX00356); 2097675-001-US, Not Applicable, (5481199-1); 1011-9050-000, 010084068210229221APWX0179111180720, (APWX01791); 1011-9050-000, 010084068210229221APWX0179211180720, (APWX01792); 1011-9050-000, 010084068210229221APWX0179311180720, (APWX01793); 1011-9050-000, 010084068210229221APWX0179411180720, (APWX01794); 1011-9050-000, 010084068210229221APWX0179511180720, (APWX01795); 1011-9050-000, 010084068210229221APWX0179611180720, (APWX01796); 1011-9050-000, 010084068210229221APWX0179711180720, (APWX01797); 1011-9050-000, 010084068210229221APWX0179811180720, (APWX01798); 1011-9050-000, 010084068210229221APWX0179911180720, (APWX01799); 1011-9050-000, 010084068210229221APWX0180011180720, (APWX01800); 1011-9050-000, 010084068210229221APWX0180111180720, (APWX01801); 1011-9050-000, 010084068210229221APWX0180211180720, (APWX01802); 1011-9050-000, 010084068210229221APWX0180311180720, (APWX01803); 1011-9050-000, 010084068210229221APWX0117311180517, (APWX01173); 1011-9050-000, 010084068210229221APWX0117411180517, (APWX01174); 1011-9050-000, 010084068210229221APWX0132911180608, (APWX01329); 1011-9050-000, 010084068210229221APWX0133011180608, (APWX01330); 1011-9050-000, 010084068210229221APWX0133111180608, (APWX01331); 1011-9050-000, 010084068210229221APWX0133211180608, (APWX01332); 1011-9050-000, 010084068210229221APWX0133311180608, (APWX01333); 1011-9050-000, 010084068210229221APWX0133411180608, (APWX01334); 1011-9050-000, 010084068210229221APWX0133511180608, (APWX01335); 1011-9050-000, 010084068210229221APWX0133611180608, (APWX01336); 1011-9050-000, 010084068210229221APWX0133711180608, (APWX01337); 1011-9050-000, 010084068210229221APWX0133811180608, (APWX01338); 1011-9050-000, 010084068210229221APWX0133911180608, (APWX01339); 2097675-001-US, Not Applicable, (5479630-2); 1011-9050-000, 010084068210229221APWW0227811171222, (APWW02278); 1011-9050-000, 010084068210229221APWX0156911180703, (APWX01569); 1011-9050-000, 010084068210229221APWX0120111180524, (APWX01201); 1011-9050-000, 010084068210229221APWX0134011180608, (APWX01340); 1011-9050-000, 010084068210229221APWX0134111180611, (APWX01341); 1011-9050-000, 010084068210229221APWX0134211180611, (APWX01342); 1011-9050-000, 010084068210229221APWX0134311180611, (APWX01343); 1011-9050-000, 010084068210229221APWX0134411180611, (APWX01344); 1011-9050-000, 010084068210229221APWX0134511180611, (APWX01345); 1011-9050-000, 010084068210229221APWX0134611180611, (APWX01346); 1011-9050-000, 010084068210229221APWX0134711180611, (APWX01347); 1011-9050-000, 010084068210229221APWX0134811180611, (APWX01348); 1011-9050-000, 010084068210229221APWX0134911180611, (APWX01349); 1011-9050-000, 010084068210229221APWX0135011180611, (APWX01350); 1011-9050-000, 010084068210229221APWX0135111180611, (APWX01351); 1011-9050-000, 010084068210229221APWX0135211180611, (APWX01352); 1011-9050-000, 010084068210229221APWX0135311180611, (APWX01353); 1011-9050-000, 010084068210229221APWX0135411180611, (APWX01354); 1011-9050-000, 010084068210229221APWX0120611180524, (APWX01206); 1011-9050-000, 010084068210229221APWX0120711180524, (APWX01207); 1011-9050-000, 010084068210229221APWX0092711180410, (APWX00927); 1011-9050-000, 010084068210229221APWX0092811180410, (APWX00928); 1011-9050-000, 010084068210229221APWX0092911180410, (APWX00929); 1011-9050-000, 010084068210229221APWX0093011180410, (APWX00930); 1011-9050-000, 010084068210229221APWX0093111180410, (APWX00931); 1011-9050-000, 010084068210229221APWX0093211180410, (APWX00932); 1011-9050-000, 010084068210229221APWX0093311180410, (APWX00933); 1011-9050-000, 010084068210229221APWX0093411180410, (APWX00934); 1011-9050-000, 010084068210229221APWX0093511180410, (APWX00935); 1011-9050-000, 010084068210229221APWX0093611180410, (APWX00936); 1011-9050-000, 010084068210229221APWX0093711180410, (APWX00937); 1011-9050-000, 010084068210229221APWX0093811180410, (APWX00938); 1011-9050-000, 010084068210229221APWX0186911180803, (APWX01869); 1011-9050-000, 010084068210229221APWX0017311180105, (APWX00173); 1011-9050-000, 010084068210229221APWX0048511180208, (APWX00485); 1011-9050-000, 010084068210229221APWW0220311171218, (APWW02203); 1011-9050-000, 010084068210229221APWW0220411171218, (APWW02204); 1011-9050-000, 010084068210229221APWW0220511171218, (APWW02205); 1011-9050-000, 010084068210229221APWW0220611171218, (APWW02206); 1011-9050-000, 010084068210229221APWW0220711171218, (APWW02207); 1011-9050-000, 010084068210229221APWW0220811171218, (APWW02208); 1011-9050-000, 010084068210229221APWW0220911171218, (APWW02209); 1011-9050-000, 010084068210229221APWW0221011171218, (APWW02210); 1011-9050-000, 010084068210229221APWW0221111171219, (APWW02211); 1011-9050-000, 010084068210229221APWX0078411180323, (APWX00784); 1011-9050-000, 010084068210229221APWX0078511180323, (APWX00785); 1011-9050-000, 010084068210229221APWX0078611180323, (APWX00786); 1011-9050-000, 010084068210229221APWX0078711180323, (APWX00787); 1011-9050-000, 010084068210229221APWX0107411180502, (APWX01074); 1011-9050-000, 010084068210229221APWX0107511180502, (APWX01075); 1011-9050-000, 010084068210229221APWX0107711180502, (APWX01077); 1011-9050-000, 010084068210229221APWX0107811180502, (APWX01078); 1011-9050-000, 010084068210229221APWX0140511180618, (APWX01405); 1011-9050-000, 010084068210229221APWX0180611180720, (APWX01806); 1011-9050-000, 010084068210229221APWX0180711180720, (APWX01807); 1011-9050-000, 010084068210229221APWX0180811180720, (APWX01808); 1011-9050-000, 010084068210229221APWX0180911180720, (APWX01809); 1011-9050-000, 010084068210229221APWX0181011180720, (APWX01810); 1011-9050-000, 010084068210229221APWX0065611180309, (APWX00656); 1011-9050-000, 010084068210229221APWX0065711180309, (APWX00657); 1011-9050-000, 010084068210229221APWX0065811180309, (APWX00658); 1011-9050-000, 010084068210229221APWX0065911180309, (APWX00659); 1011-9050-000, 010084068210229221APWX0066011180309, (APWX00660); 1011-9050-000, 010084068210229221APWX0036311180131, (APWX00363); 1011-9050-000, 010084068210229221APWX0176911180720, (APWX01769); 1011-9050-000, 010084068210229221APWX0193611180815, (APWX01936); 1011-9050-000, 010084068210229221APWX0124211180531, (APWX01242); 1011-9050-000, 010084068210229221APWX0124311180531, (APWX01243); 1011-9050-000, 010084068210229221APWX0124411180531, (APWX01244); 1011-9050-000, 010084068210229221APWX0063311180309, (APWX00633); 1011-9050-000, 010084068210229221APWX0157211180703, (APWX01572); 1011-9050-000, 010084068210229221APWX0157311180703, (APWX01573); 1011-9050-000, 010084068210229221APWX0037011180131, (APWX00370); 1011-9050-000, 010084068210229221APWV0132511160622, (APWV01325); 1011-9050-000, 010084068210229221APWX0016811180105, (APWX00168); 1011-9050-000, 010084068210229221APWX0016911180105, (APWX00169); 1011-9050-000, 010084068210229221APWX0017011180105, (APWX00170); 1011-9050-000, 010084068210229221APWX0017111180105, (APWX00171); 1011-9050-000, 010084068210229221APWX0017211180105, (APWX00172); 1011-9050-000, 010084068210229221APWX0096111180417, (APWX00961); 1011-9050-000, 010084068210229221APWX0132511180608, (APWX01325); 1011-9050-000, 010084068210229221APWX0132611180608, (APWX01326); 1011-9050-000, 010084068210229221APWX0112611180507, (APWX01126); 1011-9050-000, 010084068210229221APWX0112711180507, (APWX01127); 1011-9050-000, 010084068210229221APWX0112811180507, (APWX01128); 1011-9050-000, 010084068210229221APWX0112911180507, (APWX01129); 1011-9050-000, 010084068210229221APWX0113011180507, (APWX01130); 1011-9050-000, 010084068210229221APWX0113111180507, (APWX01131); 1011-9050-000, 010084068210229221APWX0113211180507, (APWX01132); 1011-9050-000, 010084068210229221APWX0113311180507, (APWX01133); 1011-9050-000, 010084068210229221APWX0113411180507, (APWX01134); 1011-9050-000, 010084068210229221APWX0113611180507, (APWX01136); 1011-9050-000, 010084068210229221APWX01137111

Distribution pattern

Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

device · product 3 of 3

Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Z-0413-2019
Recall number
Z-0413-2019
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
4,207 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

Code information

Model Number, UDI Number, (Serial Number): 2097673-001-US (4651698-1); 2097673-001-US (4651698-3); 2097673-001-US (4651698-4); 2097673-001-US (4651726-1); 2097673-001-US (4652206-1); 2097673-001-US (4652206-2); 2097673-001-US (4649618-1); 2097673-001-US (4649618-2); 2097673-001-US (4649618-3); 2097673-001-US (4649618-4); 2097673-001-US (4649618-5); 2097673-001-US (4653227-1); 2097673-001-US (4653227-2); 2097673-001-US (4653227-3); 2097673-001-US (5474296-1); 2097673-001-US (4652587-1); 2097673-001-US (4652587-2); 2097673-001-US (4652587-3); 2097673-001-US (4652587-4); 2097673-001-US (4652587-5); 2097673-001-US (4652587-6); 2097673-001-US (4632861-1); 2097673-001-US (4632861-2); 2097673-001-US (4632861-3); 2097673-001-US (4644953-1); 2097673-001 (5463757-1); 2097673-001 (5467309-16); 2097673-001 (5471699-1); 2097673-001 (5471699-2); 2097673-001 (5471699-3); 2097673-001 (5475515-1); 2097673-001 (5475515-2); 2097673-001 (5475516-1); 2097673-001 (5475516-10); 2097673-001 (5475516-2); 2097673-001 (5475516-3); 2097673-001 (5475516-4); 2097673-001 (5475516-5); 2097673-001 (5475516-6); 2097673-001 (5475516-7); 2097673-001 (5475516-8); 2097673-001 (5475516-9); 2097673-001 (5475528-1); 2097673-001 (5475528-10); 2097673-001 (5475528-11); 2097673-001 (5475528-12); 2097673-001 (5475528-13); 2097673-001 (5475528-14); 2097673-001 (5475528-15); 2097673-001 (5475528-16); 2097673-001 (5475528-17); 2097673-001 (5475528-18); 097673-001 (5475528-19); 2097673-001 (5475528-2); 2097673-001 (5475528-3); 2097673-001 (5475528-4); 2097673-001 (5475528-5); 2097673-001 (5475528-6); 2097673-001 (5475528-7); 2097673-001 (5475528-8); 2097673-001 (5475528-9); 2097673-001 (5481650-1); 2097673-001 (5481650-10); 2097673-001 (5481650-2); 2097673-001 (5481650-3); 097673-001 (5481650-4); 2097673-001 (5481650-5); 2097673-001 (5481650-6); 2097673-001 (5481650-7); 2097673-001 (5481650-8); 2097673-001 (5481650-9); 2097673-001 (5471701-1); 2097673-001 (5471701-2); 2097673-001 (5471702-1); 2097673-001 (5472013-1); 2097673-001 (5472013-10); 097673-001 (5472013-12); 2097673-001 (5472013-14); 2097673-001 (5472013-15); 2097673-001 (5472013-16); 2097673-001 (5472013-17); 2097673-001 (5472013-18); 2097673-001 (5472013-3); 2097673-001 (5472013-4); 2097673-001 (5472013-5); 2097673-001 (5472013-6); 2097673-001 (5472013-7); 2097673-001 (5472013-8); 2097673-001 (5463631-1); 2097673-001 (5463631-2); 2097673-001 (5466892-1); 2097673-001 (5466892-10); 2097673-001 (5466892-2); 2097673-001 (5466892-3); 2097673-001 (5466892-4); 2097673-001 (5466892-5); 2097673-001 (5466892-6); 2097673-001 (5466892-7); 2097673-001 (5466892-8); 2097673-001 (5466892-9); 2097673-DE (5480919-1); 2097673-NL (5473301-1); 2097673-NL (5473301-2); 2097673-NL (5473301-3); 2097673-NL (5473301-4); 2097673-NL (5473301-5); 2097673-NL (5473301-6); 2097673-FR (5481162-1); 2097673-NL (5481369-1); 2097673-NL (5481369-2); 2097673-NL (5481369-3); 2097673-NL (5481369-4); 2097673-NL (5481369-5); 2097673-NL (5481369-6); 2097673-NL (5481369-7); 2097673-NL (5481369-8); 2097673-NL (5481369-9); 2097673-001 (5462738-1); 2097673-001 (5462738-2); 2097673-FR (5475371-1); 2097673-FR (5475371-2); 2097673-FR (5475371-3); 2097673-FR (5475371-4); 2097673-FR (5475371-5); 2097673-FR (5479900-1); 2097673-DA (5453900-1); 2097673-ET (5461749-1); 2097673-FR (5481462-1); 2097673-FR (5481462-2); 2097673-FR (5481462-3); 2097673-FR (5481462-4); 2097673-FR (5481462-5); 2097673-FR (5481462-6); 2097673-FR (5481462-7); 2097673-FR (5481462-8); 2097673-FR (5481462-9); 2097673-FR (5473743-1); 2097673-FR (5473743-2); 2097673-FR (5473743-3); 2097673-FR (5473743-4); 2097673-FR (5473743-5); 2097673-FR (5473744-1); 2097673-FR (5473744-2); 2097673-FR (5473744-3); 2097673-FR (5473744-4); 2097673-FR (5473744-5); 2097673-FR (5473744-6); 2097673-FR (5458277-1); 2097673-FR (5458277-2); 2097673-001 (5455478-1); 2097673-IT (5476554-1); 2097673-IT (5476554-2); 2097673-IT (5476554-3); 2097673-NL (5450447-1); 2097673-NL (5450447-3); 2097673-NL (5450447-5); 2097673-NL (5450447-6); 2097673-NO (5474251-1); 2097673-001 (5476468-70); 2097673-001 (5476468-71); 2097673-001 (5476468-72); 2097673-001 (5476468-73); 2097673-001 (5476468-74); 2097673-001 (5476468-75); 2097673-001 (5476468-76); 2097673-001 (5476468-77); 2097673-001 (5476468-78); 2097673-001 (5476468-79); 2097673-001 (5476468-80); 2097673-001 (5476468-81); 2097673-001 (5476468-82); 2097673-001 (5476468-83); 2097673-001 (5476468-84); 2097673-001 (5476468-85); 2097673-001 (5476468-86); 2097673-001-US (4673852-1); 2097673-001-US (4673852-2); 2097673-001-US (4673852-3); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097673-001-US, Not Applicable, (ANAM00306); 2097673-001-US, Not Applicable, (ANAP00354); 2097673-001-US, Not Applicable, (APWU00297); 2097673-001-US, Not Applicable, (ANAP00715); 2097673-001-US, Not Applicable, (ANAR00602); 2097673-001-US, Not Applicable, (ANAR00603); 2097673-001-US, Not Applicable, (ANAN00169); 2097673-001-US, Not Applicable, (ANAP00574); 2097673-001-US, Not Applicable, (ANAP00575); 2097673-001-US, Not Applicable, (ANAP00576); 2097673-001-US, Not Applicable, (ANAP00577); 2097673-001-US, Not Applicable, (ANAQ01175); 2097673-001-US, Not Applicable, (ANAP00172); 2097673-001-US, Not Applicable, (ANAP00861); 2097673-001-US, Not Applicable, (ANAP00870); 2097673-001-US, Not Applicable, (ANAP00872); 2097673-001-US, Not Applicable, (ANAS00398 ); 2097673-001-US, Not Applicable, (ANAL00105); 2097673-001-US, Not Applicable, (ANAL00106); 2097673-001-US, Not Applicable, (ANAL00107); 2097673-001-US, Not Applicable, (ANAL00108); 2097673-001-US, Not Applicable, (ANAL00109); 2097673-001-US, Not Applicable, (ANAL00116); 2097673-001-US, Not Applicable, (ANAM00439); 2097673-001-US, Not Applicable, (ANAM00440); 2097673-001-US, Not Applicable, (ANAM00441); 2097673-001-US, Not Applicable, (ANAP01088); 2097673-001-US, Not Applicable, (ANAP01090); 2097673-001-US, Not Applicable, (ANAP01091); 2097673-001, Not Applicable, (ANAN00604); 2097673-001, Not Applicable, (ANAM01165); 2097673-001, Not Applicable, (ANAM01158); 2097673-001, Not Applicable, (ANAM00815); 2097673-001, Not Applicable, (ANAM00816); 2097673-001, Not Applicable, (ANAM00817); 2097673-001, Not Applicable, (ANAM00818); 2097673-001, Not Applicable, (ANAM00819); 2097673-001, Not Applicable, (ANAM00820); 2097673-001, Not Applicable, (ANAM00821); 2097673-001, Not Applicable, (ANAM00822); 2097673-001, Not Applicable, (ANAM00823); 2097673-001, Not Applicable, (ANAM00824); 2097673-DE, Not Applicable, (ANAP01156); 2097673-001, Not Applicable, (ANAR00318); 2097673-001, Not Applicable, (ANAR00319); 2097673-FR, Not Applicable, (ANAR05232); 2097673-FR, Not Applicable, (ANAR05233); 2097673-FR, Not Applicable, (ANAR05234); 2097673-FR, Not Applicable, (ANAR05235); 2097673-FR, Not Applicable, (ANAR05236); 2097673-FR, Not Applicable, (ANAP01419); 1011-9000-000, Not Applicable, (APWT00661); 1011-9000-000, Not Applicable, (APWT00662); 1011-9000-000, Not Applicable, (APWT00664); 1011-9000-000, Not Applicable, (ANAN00664); 1011-9000-000, Not Applicable, (ANAN00666); 1011-9000-000, Not Applicable, (ANAN00667); 1011-9000-000, Not Applicable, (ANAN00669); 1011-9000-000, Not Applicable, (ANAN00670); 1011-9000-000, Not Applicable, (ANAN00671); 1011-9000-000, Not Applicable, (ANAN00890); 1011-9000-000, Not Applicable, (ANAN00891); 1011-9000-000, Not Applicable, (ANAR00396); 1011-9000-000, Not Applicable, (APWT02012); 1011-9000-000, Not Applicable, (APWT02013); 1011-9000-000, Not Applicable, (ANAN01101); 1011-9000-000, Not Applicable, (ANAP00605); 2097673-FR, Not Applicable, (ANAQ00803); 2097673-FR, Not Applicable, (ANAQ00806); 2097673-FR, Not Applicable, (ANAQ00948); 2097673-FR, Not Applicable, (ANAR05145); 2097673-FR, Not Applicable, (ANAR05150); 2097673-FR, Not Applicable, (ANAR05513); 2097673-FR, Not Applicable, (ANAR05517); 2097673-FR, Not Applicable, (ANAS00665); 2097673-FR, Not Applicable, (ANAS00666); 2097673-FR, Not Applicable, (ANAS00668); 2097673-FR, Not Applicable, (ANAS00971); 2097673-NO, Not Applicable, (ANAQ01098);

Distribution pattern

Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.