O-arm O2 imaging system gantry support may have been damaged
The O-arm O2 Imaging System is being recalled because a mechanical component supporting the gantry to the support structure may have been damaged during manufacture. 3 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: possible manufacturing damage to a load-bearing component supporting a gantry that moves around the patient, with no injury reported in the source.
Plain-English summary
The O-arm O2 Imaging System, a mobile x-ray system, CFN BI70002000, UDI 00763000709631, is being recalled. The action covers 3 units, serial numbers C4014, C4017 and C4019.
The stated reason is that a mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. The FDA classified the action as Class II.
Distribution was nationwide in the United States, in Indiana, Minnesota and Mississippi. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected units using the CFN, UDI and serial numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- O-arm O2 Imaging System. Mobile X-Ray System.
- Manufacturer
- Medtronic Navigation, Inc.-Boxborough
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- CFN: BI70002000
- UDI: 00763000709631
- Serial No. C4014
- C4017
- C4019.
Distribution
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