Medtronic Navigation, Inc. is recalling 1,801 StealthStation S8 systems (App versions 1.3.0 and 1.3.2) used during spinal procedures. The recall was initiated because two software errors can occur: surgical images may appear flipped 180 degrees, and the system may fail to warn surgeons when image quality is not ideal for navigation. These issues can lead to incorrect placement of surgical instruments during complex procedures.
The software anomalies may cause surgeons to misinterpret the orientation of a patient's anatomy or use non-optimal images, which could result in the incorrect placement of surgical screws or implants. This poses a risk of serious injury to the patient's nerves or spinal structures during surgery.
Manufacturer Notification and Technical Guidance
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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