China NMPA Product Recall - Mobile O-arm X-ray machine

On December 20, 2019, Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its mobile O-arm X-ray machine (Registration Certificate No.: 20183300139). This action was taken under the oversight of the National Medical Products Administration (NMPA), as reported by the Shanghai Municipal Drug Administration. The recall stems from a potential for navigation inaccuracy when the device's automatic registration function is used in conjunction with image-guided surgery systems. Specifically, prolonged operation of the affected machines may lead to a loosening of the internal motor drive belt. This mechanical issue could cause the displayed image to deflect relative to the patient's actual positioning data. If this compromised image information is transmitted for O-arm registration to a navigation-intended image-guided surgery system, it introduces a risk of surgical inaccuracies. Despite identifying this potential risk, Medtronic has not received any confirmed complaints directly related to this specific issue. The company has provided further details regarding the affected product models, specifications, and batches in an accompanying Medical Device Recall Event Report Form, ensuring transparency and facilitating the recall process to safeguard patient safety.