Medtronic O-arm O2 Imaging System Recalled for Electrical Shock Risk
Medtronic is recalling 449 O-arm O2 Imaging Systems because servicing internal components may cause an electrical short, posing a shock hazard to field service technicians.
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: The recall involves a risk of electrical shock to service technicians, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Navigation, Inc. is recalling 449 units of the O-arm O2 interventional fluoroscopic x-ray system (Catalog Number: B1-700-02000). The recall is due to a potential electrical hazard that may occur during the servicing of specific internal components.
The hazard involves the high-power cable connector potentially coming into contact with surrounding metal during the disconnecting or reconnecting process. This contact may result in an electrical short and a shock to the field service technician performing the maintenance. The affected units were distributed worldwide, including nationwide in the United States and in numerous international markets.
This recall primarily affects field service technicians who perform maintenance on these systems. Medtronic is the recalling firm. The source text does not specify instructions for end-users or patients, as the risk is associated with professional servicing activities.
The recalled product
- Product
- O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of g
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Hazard
- Affected units
- 449
Distribution
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