Brand
Medtronic Navigation, Inc.-Littleton
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medtronic Navigation, Inc.-Littleton and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-06-12FDA-DeviceClass IIO-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
- 2023-08-30FDA-DeviceClass IIThe O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
Ground cable installed incorrectly.
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