China NMPA Product Recall - X-ray computed tomography equipment, X-ray computed tomography equipment

On August 18, 2020, the National Medical Products Administration (NMPA) announced that Philips Medical Systems (Cleveland), Inc., through its Chinese entity, initiated a voluntary Level III recall for certain X-ray imaging and computed tomography (CT) equipment. The primary issue identified was a malfunction in the scan bed movement during the use of these devices. This recall impacts specific models identified by Registration Certificate Numbers, including 20153062507, 20163301984, 20153060422, 20173306622, 20173302330, and 20123303860. A Level III classification signifies that the probability of serious adverse health consequences from product use is remote, or adverse health consequences are temporary and medically reversible. The required action by the company is to provide comprehensive details on all affected products, including models, specifications, and batches, within an official Medical Device Recall Event Report Form. This proactive measure ensures adherence to NMPA standards and addresses potential safety concerns related to medical device performance.