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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95045

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

Open FDA event record

Event summary

Timeline bucket
July 12, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Datex-Ohmeda, Inc.

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

11 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 11

Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0074-2025
Recall number
Z-0074-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
20,097 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

a. Aespire 7100 - GTIN: 00840682102261. Model Number: 1009-9000-000. All Serial Numbers. b. Aespire 7100 (Variant) - GTIN: 00840682102261. Model Numbers: 1009-9101-000 and 1009-9101-000. All Serial Numbers. c. Aespire 7100 S/5 Protiva - No GTIN. Model Number: 1009-9004-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 2 of 11

Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0075-2025
Recall number
Z-0075-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

GTIN: 00840682102261

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 3 of 11

Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0076-2025
Recall number
Z-0076-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
12,036 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

GTIN: 00840682102261. Model Number: 1009-9012-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 4 of 11

Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0077-2025
Recall number
Z-0077-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
10,338 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

GTIN: 00840682102285. Model Numbers: 1009-9212-000-117639, 1009-9212-000-136105, 1009-9212-000-518222, 1009-9212-000-521025, 1009-9212-000-552778, 1009-9212-000-090755, 1009-9212-000-059245, 1009-9212-000-110073, 1009-9212-000-203581, 1009-9212-000-423283, 1009-9212-000-419502, 1009-9212-000-427555, 1009-9212-000-460867, 1009-9212-000-478499, 1009-9212-000-109510, 1009-9212-000-521303, 1009-9212-000-097620, 1009-9212-000-102602, 1009-9212-000-520908, 1009-9212-000-098765, 1009-9212-000-076846, 1009-9212-000-070149, 1009-9212-000-189720, 1009-9212-000-140832, 1009-9212-000-036279, 1009-9212-000-484467, 1009-9212-000-520055, 1009-9212-000-516124, 1009-9212-000-182799, 1009-9212-000-161253, 1009-9212-000-121684, 1009-9212-000-117998, 1009-9212-000-499121, 1009-9212-000-405786, 1009-9212-000-425988, 1009-9212-000-309943, 1009-9212-000-045250, 1009-9212-000-121264, 1009-9212-000-478484, 1009-9212-000-184939, 1009-9212-000-513915, 1009-9212-000-049292, 1009-9212-000-467900, 1009-9212-000-521309, 1009-9212-000-243610, 1009-9212-000-431587, 1009-9212-000-089004, 1009-9212-000-248292, 1009-9212-000-308148, 1009-9212-000-115588, 1009-9212-000-479608, 1009-9212-000-048968, 1009-9212-000-486460, 1009-9212-000-421908, 1009-9212-000-050573, 1009-9212-000-309081, 1009-9212-000-091588, 1009-9212-000-051332, 1009-9212-000-097158, 1009-9212-000-276899, 1009-9212-000-053315, 1009-9212-000-081578, 1009-9212-000-109837, 1009-9212-000-049346, 1009-9212-000-090939, 1009-9212-000-078248, 1009-9212-000-327595, 1009-9212-000-419939, 1009-9212-000-087052, 1009-9212-000-098097, 1009-9212-000-485388, 1009-9212-000-478445, 1009-9212-000-093971, 1009-9212-000-395920, 1009-9212-000-208521, 1009-9212-000-509210, 1009-9212-000-363293, 1009-9212-000-521749, 1009-9212-000-376941, 1009-9212-000-198472, 1009-9212-000-456812, 1009-9212-000-107405, 1009-9212-000-306850, 1009-9212-000-536898, 1009-9212-000-258372, 1009-9212-000-517270, 1009-9212-000-161437, 1009-9212-000-505558, 1009-9212-000-249707, 1009-9212-000-117997, 1009-9212-000-158013, 1009-9212-000-278077, 1009-9212-000-440857, 1009-9212-000-081912, 1009-9212-000-109354, 1009-9212-000-426548, 1009-9212-000-070483, 1009-9212-000-171605, 1009-9212-000-518138, 1009-9212-000-198653, 1009-9212-000-218924, 1009-9212-000-134925, 1009-9212-000-543830, 1009-9212-000-483749, 1009-9212-000-088663, 1009-9212-000-117186, 1009-9212-000-355056, 1009-9212-000-051610, 1009-9212-000-087880, 1009-9212-000-232443, 1009-9212-000-095799, 1009-9212-000-158807, 1009-9212-000-062178, 1009-9212-000-050286, 1009-9212-000-093974, 1009-9212-000-101413, 1009-9212-000-053197, 1009-9212-000-440154, 1009-9212-000-114872, 1009-9212-000-159667, 1009-9212-000-109331, 1009-9212-000-223652, 1009-9212-000-048197, 1009-9212-000-058291, 1009-9212-000-302056, 1009-9212-000-122193, 1009-9212-000-078293, 1009-9212-000-246469, 1009-9212-000-160553, 1009-9212-000-160339, 1009-9212-000-471361, 1009-9212-000-518135, 1009-9212-000-166903, 1009-9212-000-118964, 1009-9212-000-141489, 1009-9212-000-076650, 1009-9212-000-054353, 1009-9212-000-096943, 1009-9212-000-259132, 1009-9212-000-535385, 1009-9212-000-532475, 1009-9212-000-515662, 1009-9212-000-077555, 1009-9212-000-554236, 1009-9212-000-065564, 1009-9212-000-392814, 1009-9212-000-070095, 1009-9212-000-212132, 1009-9212-000-506712, 1009-9212-000-140089, 1009-9212-000-080258, 1009-9212-000-110337, 1009-9212-000-555039, 1009-9212-000-514978, 1009-9212-000-054915, 1009-9212-000-139427, 1009-9212-000-047388, 1009-9212-000-117857, 1009-9212-000-071109, 1009-9212-000-117679, 1009-9212-000-145786, 1009-9212-000-080958, 1009-9212-000-183258, 1009-9212-000-048398, 1009-9212-000-471840, 1009-9212-000-065565, 1009-9212-000-093950, 1009-9212-000-107842, 1009-9212-000-210481, 1009-9212-000-160187, 1009-9212-000-080818, 1009-9212-000-498484, 1009-9212-000-544026, 1009-9212-000-084762, 1009-9212-000-344393, 1009-9212-000-423319, 1009-9212-000-185541, 1009-9212-000-092367, 1009-9212-000-146320, 1009-9212-000-076140, 1009-9212-000-418361, 1009-9212-000-141571, 1009-9212-000-048868, 1009-9212-000-067380, 1009-9212-000-098076, 1009-9212-000-525824, 1009-9212-000-048871, 1009-9212-000-076829, 1009-9212-000-158867, 1009-9212-000-298874, 1009-9212-000-356496, 1009-9212-000-422510, 1009-9212-000-050353, 1009-9212-000-118000, 1009-9212-000-553021, 1009-9212-000-055437, 1009-9212-000-091670, 1009-9212-000-064401, 1009-9212-000-090074, 1009-9212-000-097159, 1009-9212-000-394486, 1009-9212-000-284713, 1009-9212-000-068616, 1009-9212-000-474791, 1009-9212-000-403039, 1009-9212-000-101806, 1009-9212-000-229743, 1009-9212-000-521243, 1009-9212-000-077182, 1009-9212-000-046598, 1009-9212-000-424460, 1009-9212-000-045997, 1009-9212-000-052771, 1009-9212-000-073085, 1009-9212-000-084634, 1009-9212-000-199153, 1009-9212-000-380221, 1009-9212-000-524962, 1009-9212-000-154721, 1009-9212-000-399996, 1009-9212-000-094885, 1009-9212-000-521981, 1009-9212-000-074668, 1009-9212-000-418440, 1009-9212-000-048178, 1009-9212-000-053273, 1009-9212-000-058705, 1009-9212-000-059685, 1009-9212-000-061458, 1009-9212-000-068797, 1009-9212-000-068860, 1009-9212-000-069423, 1009-9212-000-070363, 1009-9212-000-077431, 1009-9212-000-085501, 1009-9212-000-088172, 1009-9212-000-088366, 1009-9212-000-108938, 1009-9212-000-137865, 1009-9212-000-144906, 1009-9212-000-148641, 1009-9212-000-149305, 1009-9212-000-156421, 1009-9212-000-156082, 1009-9212-000-168663, 1009-9212-000-189680, 1009-9212-000-167083, 1009-9212-000-216127, 1009-9212-000-192542, 1009-9212-000-257732, 1009-9212-000-24607066, 1009-9212-000-311360, 1009-9212-000-333375, 1009-9212-000-337550, 1009-9212-000-394126, 1009-9212-000-451967, 1009-9212-000-506833, 1009-9212-000-510289, 1009-9212-000-512961, 1009-9212-000-249630, 1009-9212-000-382295, 1009-9212-000-318511, 1009-9212-000-482708, 1009-9212-000-430055, 1009-9212-000-109716, 1009-9212-000-518951, 1009-9212-000-529858, 1009-9212-000-493160, 1009-9212-000-535831, 1009-9212-000-368669, 1009-9212-000-406738, 1009-9212-000-497438, 1009-9212-000-352697, 1009-9212-000-423551, 1009-9212-000-432678, 1009-9212-000-432677, 1009-9212-000-508327, 1009-9212-000-091138, 1009-9212-000-043536, 1009-9212-000-219380, 1009-9212-000-427570, 1009-9212-000-271333, 1009-9212-000-493032, 1009-9212-000-089598, 1009-9212-000-125342, 1009-9212-000-543720, 1009-9212-000-151100, 1009-9212-000-397632, 1009-9212-000-123332, 1009-9212-000-174349, 1009-9212-000-115639, 1009-9212-000-531795, 1009-9212-000-109390, 1009-9212-000-427679, 1009-9212-000-359558, 1009-9212-000-512244, 1009-9212-000-120278, 1009-9212-000-191881, 1009-9212-000-109970, 1009-9212-000-397692, 1009-9212-000-189162, 1009-9212-000-423355, 1009-9212-000-105845, 1009-9212-000-089265, 1009-9212-000-077192, 1009-9212-000-398112, 1009-9212-000-111266, 1009-9212-000-150144, 1009-9212-000-522033, 1009-9212-000-105007, 1009-9212-000-135965, 1009-9212-000-427455, 1009-9212-000-084494, 1009-9212-000-120283, 1009-9212-000-105265, 1009-9212-000-121344, 1009-9212-000-460142, 1009-9212-000-094553, 1009-9212-000-174788, 1009-9212-000-159167, 1009-9212-000-402678, 1009-9212-000-540754, 1009-9212-000-104750, 1009-9212-000-107951, 1009-9212-000-122252, 1009-9212-000-061180, 1009-9212-000-203595, 1009-9212-000-093250, 1009-9212-000-242874, 1009-9212-000-066173, 1009-9212-000-083159, 1009-9212-000-096749, 1009-9212-000-095091, 1009-9212-000-143011, 1009-9212-000-147180, 1009-9212-000-103721, 1009-9212-000-540755, 1009-9212-000-572447, 1009-9212-000-098134, 1009-9212-000-043949, 1009-9212-000-372798, 1009-9212-000-070425, 1009-9212-000-471459, 1009-9212-000-537158, 1009-9212-000-069742, 1009-9212-000-118777, 1009-9212-000-398113, 1009-9212-000-048029, 1009-9212-000-187506, 1009-9212-000-291269, 1009-9212-000-062382, 1009-9212-000-061368, 1009-9212-000-089905, 1009-9212-000-435100, 1009-9212-000-043205, 1009-9212-000-114698, 1009-9212-000-141209, 1009-9212-000-500483, 1009-9212-000-061367, 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1009-9212-000-154521, 1009-9212-000-187840, 1009-9212-000-195103, 1009-9212-000-224133, 1009-9212-000-225318, 1009-9212-000-073764, 1009-9212-000-153422, 1009-9212-000-087112, 1009-9212-000-055499, 1009-9212-000-106463, 1009-9212-000-189385, 1009-9212-000-480407, 1009-9212-000-529911, 1009-9212-000-114043, 1009-9212-000-215464, 1009-9212-000-431522, 1009-9212-000-111245, 1009-9212-000-090647, 1009-9212-000-151460, 1009-9212-000-241973, 1009-9212-000-060156, 1009-9212-000-120315, 1009-9212-000-538081, 1009-9212-000-507815, 1009-9212-000-532669, 1009-9212-000-421837, 1009-9212-000-079100, 1009-9212-000-143331, 1009-9212-000-146262, 1009-9212-000-193363, 1009-9212-000-450550, 1009-9212-000-439316, 1009-9212-000-447206, 1009-9212-000-460304, 1009-9212-000-463455, 1009-9212-000-480249, 1009-9212-000-498321, 1009-9212-000-153701, 1009-9212-000-410840, 1009-9212-000-516216, 1009-9212-000-514476, 1009-9212-000-107403, 1009-9212-000-423597, 1009-9212-000-114238, 1009-9212-000-397095, 1009-9212-000-049525, 1009-9212-000-073466, 1009-9212-000-086140, 1009-9212-000-509441, 1009-9212-000-510213, 1009-9212-000-046925, 1009-9212-000-280521, 1009-9212-000-416999, 1009-9212-000-298692, 1009-9212-000-087171, 1009-9212-000-541250, 1009-9212-000-112034, 1009-9212-000-049246, 1009-9212-000-058137, 1009-9212-000-424095, 1009-9212-000-075391, 1009-9212-000-051629, 1009-9212-000-055895, 1009-9212-000-200169, 1009-9212-000-467712, 1009-9212-000-122353, 1009-9212-000-197283, 1009-9212-000-371531, 1009-9212-000-385369, 1009-9212-000-420979, 1009-9212-000-121953, 1009-9212-000-077474, 1009-9212-000-517447, 1009-9212-000-423988, 1009-9212-000-456572, 1009-9212-000-094170, 1009-9212-000-103980, 1009-9212-000-093910, 1009-9212-000-079246, 1009-9212-000-499619, 1009-9212-000-252101, 1009-9212-000-048161, 1009-9212-000-332475, 1009-9212-000-110948, 1009-9212-000-175403, 1009-9212-000-086414, 1009-9212-000-110965, 1009-9212-000-423320, 1009-9212-000-180559, 1009-9212-000-080479, 1009-9212-000-461191, 1009-9212-000-461583, 1009-9212-000-461865, 1009-9212-000-107231, 1009-9212-000-098291, 1009-9212-000-497117, 1009-9212-000-116827, 1009-9212-000-241132, 1009-9212-000-463672, 1009-9212-000-346626, 1009-9212-000-374935, 1009-9212-000-115449, 1009-9212-000-084761, 1009-9212-000-093179, 1009-9212-000-228901, 1009-9212-000-503000, 1009-9212-000-248089, 1009-9212-000-481328, 1009-9212-000-144552, 1009-9212-000-175122, 1009-9212-000-195423, 1009-9212-000-116247, 1009-9212-000-055498, 1009-9212-000-078151, 1009-9212-000-046000, 1009-9212-000-181859, 1009-9212-000-199058, 1009-9212-000-285624, 1009-9212-000-242656, 1009-9212-000-142251, 1009-9212-000-181219, 1009-9212-000-085702, 1009-9212-000-084902, 1009-9212-000-036554, 1009-9212-000-086453, 1009-9212-000-086184, 1009-9212-000-178174, 1009-9212-000-072949, 1009-9212-000-104993, 1009-9212-000-414366, 1009-9212-000-309379, 1009-9212-000-162134, 1009-9212-000-179437, 1009-9212-000-051898, 1009-9212-000-355117, 1009-9212-000-053716, 1009-9212-000-368478, 1009-9212-000-171775, 1009-9212-000-060194, 1009-9212-000-069116, 1009-9212-000-074707, 1009-9212-000-063200, 1009-9212-000-520595, 1009-9212-000-379703, 1009-9212-000-044734, 1009-9212-000-393606, 1009-9212-000-507361, 1009-9212-000-048057, 1009-9212-000-086655, 1009-9212-000-081913, 1009-9212-000-094903, 1009-9212-000-120128, 1009-9212-000-070283, 1009-9212-000-081558, 1009-9212-000-094881, 1009-9212-000-093106, 1009-9212-000-086654, 1009-9212-000-410461, 1009-9212-000-059405, 1009-9212-000-078869, 1009-9212-000-047737, 1009-9212-000-094882, 1009-9212-000-408275, 1009-9212-000-529944, 1009-9212-000-380746, 1009-9212-000-241410, 1009-9212-000-068795, 1009-9212-000-093516, 1009-9212-000-056217, 1009-9212-000-139628, 1009-9212-000-138608, 1009-9212-000-297055, 1009-9212-000-174562, 1009-9212-000-416147, 1009-9212-000-239169, 1009-9212-000-048822, 1009-9212-000-589851, 1009-9212-000-584249, 1009-9212-000-583811, 1009-9212-000-599077, 1009-9212-000-599007, 1009-9212-000-599100, 1009-9212-000-502918, 1009-9212-000-073687, 1009-9212-000-082332, 1009-9212-000-145888, 1009-9212-000-252517, 1009-9212-000-496012, 1009-9212-000-509269, 1009-9212-000-431481, 1009-9212-000-149081, 1009-9212-000-461422, 1009-9212-000-189821, 1009-9212-000-104691, 1009-9212-000-067540, 1009-9212-000-075145, 1009-9212-000-153201, 1009-9212-000-390541, 1009-9212-000-423506, 1009-9212-000-297321, 1009-9212-000-147680, 1009-9212-000-136985, 1009-9212-000-048973, 1009-9212-000-071865, 1009-9212-000-359021, 1009-9212-000-472003, 1009-9212-000-069543, 1009-9212-000-069075, 1009-9212-000-250517, 1009-9212-000-056856, 1009-9212-000-100120, 1009-9212-000-100062, 1009-9212-000-138527, 1009-9212-000-090646, 1009-9212-000-070989, 1009-9212-000-115668, 1009-9212-000-135367, 1009-9212-000-119456, 1009-9212-000-137908, 1009-9212-000-160391, 1009-9212-000-046628, 1009-9212-000-197982, 1009-9212-000-144787, 1009-9212-000-440014, 1009-9212-000-523180, 1009-9212-000-081872, 1009-9212-000-082810, 1009-9212-000-420862, 1009-9212-000-083660, 1009-9212-000-502293, 1009-9212-000-342003, 1009-9212-000-119774, 1009-9212-000-228045, 1009-9212-000-274351, 1009-9212-000-356956, 1009-9212-000-414006, 1009-9212-000-414326, 1009-9212-000-418266, 1009-9212-000-426630, 1009-9212-000-443108, 1009-9212-000-467201, 1009-9212-000-467212, 1009-9212-000-497186, 1009-9212-000-509277, 1009-9212-000-521881, 1009-9212-000-524838, 1009-9212-000-526150, 1009-9212-000-054855, 1009-9212-000-191343, 1009-9212-000-045077, 1009-9212-000-438034, 1009-9212-000-501230, 1009-9212-000-275056, 1009-9212-000-156481, 1009-9212-000-444128, 1009-9212-000-040642, 1009-9212-000-047901, 1009-9212-000-091217, 1009-9212-000-193023, 1009-9212-000-274450, 1009-9212-000-527543, 1009-9212-000-243952, 1009-9212-000-412706, 1009-9212-000-412488, 1009-9212-000-065643, 1009-9212-000-370776, 1009-9212-000-443151, 1009-9212-000-055515, 1009-9212-000-302712, 1009-9212-000-390181, 1009-9212-000-173824, 1009-9212-000-367694, 1009-9212-000-137567, 1009-9212-000-517261, 1009-9212-000-411700, 1009-9212-000-388321, 1009-9212-000-086342, 1009-9212-000-102927, 1009-9212-000-105125, 1009-9212-000-390501, 1009-9212-000-450448, 1009-9212-000-361198, 1009-9212-000-411660, 1009-9212-000-187124, 1009-9212-000-251482, 1009-9212-000-056075, 1009-9212-000-094614, 1009-9212-000-107628, 1009-9212-000-078132, 1009-9212-000-052612, 1009-9212-000-390976, 1009-9212-000-499791, 1009-9212-000-526781, 1009-9212-000-367713, 1009-9212-000-046044, 1009-9212-000-431245, 1009-9212-000-306268, 1009-9212-000-264332, 1009-9212-000-257036, 1009-9212-000-046656, 1009-9212-000-057080, 1009-9212-000-163012, 1009-9212-000-231001, 1009-9212-000-259575, 1009-9212-000-283028, 1009-9212-000-086022, 1009-9212-000-154164, 1009-9212-000-069785, 1009-9212-000-103306, 1009-9212-000-105537, 1009-9212-000-052819, 1009-9212-000-276130, 1009-9212-000-384306, 1009-9212-000-303632, 1009-9212-000-532343, 1009-9212-000-059802, 1009-9212-000-215368, 1009-9212-000-181917, 1009-9212-000-070284, 1009-9212-000-110451, 1009-9212-000-086021, 1009-9212-000-165424, 1009-9212-000-275632, 1009-9212-000-302173, 1009-9212-000-509751, 1009-9212-000-174761, 1009-9212-000-222027, 1009-9212-000-070064, 1009-9212-000-105426, 1009-9212-000-508350, 1009-9212-000-055415, 1009-9212-000-449366, 1009-9212-000-377235, 1009-9212-000-170705, 1009-9212-000-151441, 1009-9212-000-169703, 1009-9212-000-496155, 1009-9212-000-467453, 1009-9212-000-391302, 1009-9212-000-069783, 1009-9212-000-260773, 1009-9212-000-414049, 1009-9212-000-509161, 1009-9212-000-559203, 1009-9212-000-296296, 1009-9212-000-421197, 1009-9212-000-518108, 1009-9212-000-172099, 1009-9212-000-245232, 1009-9212-000-245234, 1009-9212-000-381686, 1009-9212-000-077829, 1009-9212-000-082234, 1009-9212-000-053516, 1009-9212-000-105664, 1009-9212-000-343033, 1009-9212-000-389781, 1009-9212-000-057274, 1009-9212-000-113328, 1009-9212-000-244531, 1009-9212-000-187521, 1009-9212-000-216605, 1009-9212-000-050472, 1009-9212-000-103067, 1009-9212-000-115148, 1009-9212-000-150722, 1009-9212-000-362034, 1009-9212-000-175923, 1009-9212-000-535977, 1009-9212-000-386897, 1009-9212-000-095000, 1009-9212-000-052692, 1009-9212-000-358356, 1009-9212-000-524002, 1009-9212-000-105424, 1009-9212-000-110552, 1009-9212-000-176044, 1009-9212-000-244532, 1009-9212-000-514239, 1009-9212-000-045786, 1009-9212-000-095900, 1009-9212-000-103788, 1009-9212-000-391295, 1009-9212-000-091593, 1009-9212-000-114652, 1009-9212-000-060732, 1009-9212-000-053975, 1009-9212-000-403518, 1009-9212-000-496876, 1009-9212-000-067855, 1009-9212-000-388584, 1009-9212-000-182439, 1009-9212-000-362057, 1009-9212-000-399436, 1009-9212-000-107846, 1009-9212-000-439434, 1009-9212-000-094603, 1009-9212-000-165825, 1009-9212-000-190163, 1009-9212-000-436254, 1009-9212-000

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 5 of 11

Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0078-2025
Recall number
Z-0078-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
9,349 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

GTIN: 00840682102322. Model Number: 1009-9002-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 6 of 11

Amingo. OUS only.

Z-0079-2025
Recall number
Z-0079-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
77 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

GTIN: 00840682102322. Model Number: 1009-9013-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 7 of 11

Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0080-2025
Recall number
Z-0080-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
12,559 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

GTIN: 00840682102322. Model Numbers: 1009-9050-000, 1011-9050-000, 1009-9002-000, 1009-9212-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 8 of 11

Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0081-2025
Recall number
Z-0081-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
4,790 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

GTIN: 00840682102292. Model Number: 1011-9000-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 9 of 11

Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0082-2025
Recall number
Z-0082-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
15,739 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

GTIN: 00840682102292. Model Number: 1011-9050-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 10 of 11

Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Z-0083-2025
Recall number
Z-0083-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
92 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

GTIN: 00195278588128. Model Number: 1011-9055-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

device · product 11 of 11

Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.

Z-0084-2025
Recall number
Z-0084-2025
Initiated
July 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Datex-Ohmeda, Inc.
Quantity
649 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Code information

No GTIN. Spare Part Numbers: 1009-8249-000, 1011-8071-000. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.