Z-2101-2025 Class II Ongoing
FDA device recall Z-2101-2025 was initiated by Medtronic Navigation, Inc.-Boxborough on May 27, 2025 and is designated Class II. Reason for recall: A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. The recall status is ongoing. Affected quantity: 3 units.
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.