Recall archive / FDA device enforcement
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) — FDA record Z-0861-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 8, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 108 systems (14 US, 1 Canada, 93 ROW)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0861-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | (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; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 7, 2024
- Recall initiation date
- Dec 8, 2023
- Center classification date
- Jan 30, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.