Surgical imaging device electrical component may intermittently shut off
The O-arm O2 surgical imaging system may experience intermittent electrical failure affecting intraoperative imaging guidance. The recall involves 20 units distributed in 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported hospitalizations, injuries, or documented adverse events. The hazard is a potential electrical malfunction without confirmed patient harm, making this a precautionary device recall that warrants Moderate severity.
Plain-English summary
The O-arm O2 Imaging System is a mobile x-ray device used for 2D fluoroscopic and 3D imaging in surgical settings for both adult and pediatric patients. Medtronic Navigation, Inc. has issued a Class II recall for 20 units.
An electrical component of the device may intermittently shut off during operation. When this occurs, it can result in loss of image guidance during surgery, potentially requiring surgical delay, rescheduling, cancellation, or completion of the procedure without the benefit of real-time imaging.
The affected devices are distributed worldwide, including in US states Arizona, California, Colorado, Connecticut, Florida, Minnesota, Puerto Rico, Texas, and Wisconsin, as well as Bangladesh, Canada, Costa Rica, India, Mexico, Panama, and the Philippines.
Healthcare facilities with devices matching the affected serial numbers should contact Medtronic for guidance on remediation. Complete serial numbers and GTINs are available through the FDA recall notice.
The recalled product
- Product
- O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Affected units
- 20
Distribution
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