Device product
O-arm O2 Imaging System. Mobile X-Ray System.
Z-2101-2025
Product summary
- Event
- Event 97045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2101-2025
Official wording
Reason: A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Code information: CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
Distribution pattern: US Nationwide distribution in the states of IN, MN, MS.
Derived failure modes
-
Unknown
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.