Z-0860-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- December 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 systems (9 US, 1 Canada, 18 ROW)
Product Description
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Reason for Recall
Loss of connectivity between the FlexArm and the Table due to a software issue.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
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;