FDA Medical devices recall ·
O-arm O2 Imaging System recall
- Recall number
- Z-2101-2025
- Date
- (initiated May 27, 2025)
- Company / brand
- Medtronic Navigation, Inc.-Boxborough
200 Beaver Brook Road, Boxborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
O-arm O2 Imaging System. Mobile X-Ray System.
Why was it recalled?
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
Distribution
US Nationwide distribution in the states of IN, MN, MS.
States: Indiana Minnesota Mississippi
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2101-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.