Medtronic Navigation, Inc.-Boxborough is recalling 3 units of the O-arm O2 Imaging System, a mobile X-ray device used in clinical settings. A mechanical component that supports the imaging gantry to its support structure may have been damaged during the manufacturing process. Consumers should stop using the affected devices and contact the manufacturer or their distributor to arrange for a return or repair.
The damaged mechanical component could compromise the structural integrity of the device gantry. This may lead to the gantry becoming unstable or failing during use, potentially causing injury to patients or medical staff during imaging procedures.
Units Affected: 3
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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