O-arm O2 Imaging System. Mobile X-Ray System.
Reported: July 16, 2025 Initiated: May 27, 2025 #Z-2101-2025
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.
Details
- Recalling Firm
- Medtronic Navigation, Inc.-Boxborough
- Units Affected
- 3 units
- Distribution
- US Nationwide distribution in the states of IN, MN, MS.
- Location
- Boxborough, MA
Frequently Asked Questions
What product was recalled? ▼
O-arm O2 Imaging System. Mobile X-Ray System.. Recalled by Medtronic Navigation, Inc.-Boxborough. Units affected: 3 units.
Why was this product recalled? ▼
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2025. Severity: Moderate. Recall number: Z-2101-2025.
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