Reported Jun 12, 2024 · Ongoing
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric…
Medtronic Navigation, Inc.-Littleton
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc.-Littleton · 300 Foster St · Littleton, MA · 01460-2017
Is this the product you have?
- O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients
- Product NumberBI70002000
- Lot codes and dates
- GTIN00643169639683 00763000616441 00763000616465 00763000616526 00763000616533 00763000616564 00763000616571
- Serial Numbers
C3578C3421C3606C3645C3641C3589C3604C3537C3551C1595C1437C3469C3635C3626C3389C3647C3407C3713C3607C1629
- Amount recalled
- 20 units
Where it was sold
Why it was recalled
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
This product could cause temporary or reversible health problems — stop using it.
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