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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93734

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 08, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

1 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 1

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

Z-0861-2024
Recall number
Z-0861-2024
Initiated
December 08, 2023
Classification
Class II
Status
Ongoing
Quantity
108 systems (14 US, 1 Canada, 93 ROW)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue related to the date/time format. This connection issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.

Code information

(1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1005, 866, 1361, 952, 1241, 1169, 756, 703351, 1135, 1122, 824, 748, 630, 638, 703385, 812, 703346, 1303, 1313, 893, 768, 929, 703638, 1357, 703810, 934, 1202, 703461, 703706, 1172, 703959, 703845, 703705; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 539, 395, 278, 134, 730, 252, 370, 36, 572, 645, 272, 495, 781, 62, 1388, 352, 1655, 690, 555, 895, 2165, 861, 60, 20, 648, 2231, 1778, 1431, 778, 477, 917, 1718, 388, 2042, 150, 764, 2036, 1421, 157, 879, 212, 144, 1463, 347, 575, 2187, 355, 2576, 1332, 424, 387, 863, 211, 474, 712, 549, 2309, 799, 2283, 639, 1700, 2071, 537, 1589, 2208, 2057, 771, 772, 1216, 1667;

Distribution pattern

Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.