Medtronic O-arm O2 imaging systems may produce image artifacts
Medtronic O-arm O2 Imaging Systems are being recalled because an anomaly in the detector panel firmware may cause image artifacts. 589 units are 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: FDA Class II recall where imaging used during a procedure may show artifacts, a risk of harm with no injuries reported in the source.
Plain-English summary
The Medtronic O-arm O2 Imaging System, model number BI70002000, is being recalled. The action covers 589 units, identified by the GTIN and serial numbers in the recall notice.
The stated reason is the potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System's detector panel firmware. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States and to Albania, Algeria and other markets. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the model number and serial numbers in the recall notice and follow the instructions issued by Medtronic.
The recalled product
- Product
- Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
- Manufacturer
- Medtronic Navigation, Inc.-Boxborough
- Affected units
- 589
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 (20)
- Model Number: BI70002000. GTIN (Serial Numbers): 00643169639683 (C1640)
- 00643169651814 (C3815
- C3816
- C3817
- C3818
- C3891
- C3898
- C3899
- C3900
- C3901
- C3902
- C3903
- C3905
- C3990
- C3997
- C3998
- C3999
- C4001
- C4002
- C4003
Distribution
Distributed nationwide across the United States.
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