[pending] Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Pending LLM rewrite. Source: FDA_DEVICE Z-2451-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
The recalled product
- Product
- Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
- Manufacturer
- Medtronic Navigation, Inc.-Boxborough
- Category
- Medical Device — Devices
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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