Reported Aug 30, 2023 · Ongoing
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and…
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?
- The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published BI70002000— — 0076300007412800763000081041007630003555550076300049678400763000542801007630006164340076300061652600763000616564UDI-DI: 00763000074128, 00763000081041, 00763000355555, 00763000496784, 00763000542801, 00763000616434, 00763000616526, 00763000616564 — Serial No. C2786, C2841, C2781, C2624, C2659, C2660, C2665, C2672, C2708, C2723, C2735, C2760, C2774, C2775, C2779, C2798, C2814, C2823, C2873, C2918, C2968, C3290, C3363, C3188, C3322, C3387, C3404, and C3418. - Amount recalled
- 28 units
Where it was sold
Why it was recalled
Ground cable installed incorrectly.
This product could cause temporary or reversible health problems — stop using it.
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