Device product
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Z-0860-2024
Product summary
- Event
- Event 93721
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28 systems (9 US, 1 Canada, 18 ROW)
- Official record key
device-enforcement:Z-0860-2024
Official wording
Reason: Loss of connectivity between the FlexArm and the Table due to a software issue.
Code information: (1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1086, 1392, 703615, 1079, 743, 703456, 1248; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 1337, 1249, 1925, 1250, 468, 379, 647, 633, 1534, 887, 1349, 280, 969, 197, 1177, 455, 3, 2611, 2716, 606, 2025;
Distribution pattern: Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
Derived failure modes
-
Device software or design
software issue