Medtronic Navigation, Inc. has recalled 20 units of the O-arm O2 Imaging System, a mobile x-ray system used for 2D and 3D imaging in both adult and pediatric surgeries. An electrical component in the system may intermittently shut off, which can lead to surgical delays, the need for additional imaging, or even the cancellation and rescheduling of operations. In some cases, surgeries may be completed without the intended benefit of image guidance. Consumers and healthcare facilities should contact Medtronic immediately for instructions on the next steps for these specific units.
The device may unexpectedly lose power during a procedure due to a faulty electrical component, which can leave surgeons without real-time imaging data. This failure can increase the time a patient is under anesthesia or result in a surgery being performed without the necessary visual guidance, increasing the risk of procedural errors.
Contact manufacturer for potential repair or technical support
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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