O-arm O2 Imaging System Ground Cable Installation Defect Recall
Medtronic is recalling O-arm O2 imaging systems due to an incorrectly installed ground cable. The defect affects 28 units distributed across the US and internationally.
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 medical device recall with a structural installation defect (improper ground cable connection) that poses electrical safety risk. No injuries or illnesses have been reported, but the defect qualifies as a risk-of-harm product without documented injury, per the severity rubric.
Plain-English summary
Medtronic Navigation, Inc. is recalling the O-arm O2 Imaging System, a mobile x-ray system used for 2D fluoroscopic and 3D imaging in surgical and interventional settings.
The recall addresses a manufacturing/installation defect: the ground cable on affected units has been installed incorrectly. This creates a potential electrical safety risk to patients and operators.
The recall affects 28 units distributed across 16 US states (California, Colorado, Florida, Iowa, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, Nevada, Ohio, Tennessee, Utah, Virginia, and Washington) and six countries (Canada, Ireland, Poland, Russian Federation, Switzerland, and Vietnam). Affected units are identified by Model No. BI70002000 with specific serial numbers listed in the FDA recall notice.
Healthcare facilities with affected equipment should contact Medtronic immediately for remediation instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Affected units
- 28
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 No. BI70002000
- UDI-DI: 00763000074128
- 00763000081041
- 00763000355555
- 00763000496784
- 00763000542801
- 00763000616434
- 00763000616526
- 00763000616564
- Serial No. C2786
- C2841
- C2781
- C2624
- C2659
- C2660
- C2665
- C2672
- C2708
- C2723
- C2735
Distribution
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