The 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.

Customers were sent recall notification via UPS 2-day delivery on 7/25/2023. The recall notification informs consignees they may continue to use the device per facility protocol; there is no risk to the patient or user when system panels remain intact. Consignees are to inform all personnel in all care environments in with the recalled device is used about the provided Medical Device Correction Notice and to post copies of the notification in a prominent location to maintain awareness until the issue is resolved by a Medtronic Field Service Engineer. Consignees are to complete and return the provided customer confirmation form via email to [email protected]. If consignees are aware of any incidents related to this recall, they are to contact Technical Support immediately by phone at 1-888-826-5603 or by mail at [email protected]. Medtronic will schedule a service visit to correct this issue but if consignees have any questions regarding this issue in the interim, contact Technical Services for help at 1-800-595-9709 (US) or 1-700-890-3160 (OUS) and reference FA1351.