China NMPA Product Recall - X-ray computed tomography equipment (incisive CT, MX16-slice and Access CT scanning beds)

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class II recall for specific X-ray Computed Tomography (CT) equipment models, including Incisive CT, MX16-slice, and Access CT scanning beds. The recall, publicized on February 25, 2021, follows internal testing that revealed a critical defect: pushrod motors in these scanning beds may cause unexpected and slow downward movement, posing a potential safety risk. This proactive measure is being implemented under the regulatory framework of the National Medical Products Administration (NMPA), with the initial notification appearing via the Jiangsu Provincial Drug Administration. The Class II designation indicates that the issue could lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. Required actions involve the immediate implementation of this recall, with comprehensive details regarding the specific affected products and the scope of the recall available in a designated "Medical Device Recall Event Report Form." This action underscores the company's commitment to ensuring patient safety and product reliability.