Z-2101-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 16, 2025
- Initiation Date
- May 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
O-arm O2 Imaging System. Mobile X-Ray System.
Reason for Recall
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Distribution Pattern
US Nationwide distribution in the states of IN, MN, MS.
Code Information
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.