China NMPA Product Recall - X-ray computed tomography (CT) equipment; X-ray computed tomography equipment

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its X-ray Computed Tomography (CT) equipment, as announced by the National Medical Products Administration (NMPA) on June 10, 2021. The recall stems from a critical safety concern where severe wear on the monitor bracket assembly shaft was not adequately identified. This oversight could lead to the monitor bracket assembly detaching from the suspension arm, posing a potential risk to users and patients. The recall was reported by the company and published by the Shanghai Municipal Drug Administration. Affected devices include multiple models of CT equipment, identified by specific CFDA Registration Numbers. Detailed information regarding the affected product models, specifications, and batches is available in the accompanying "Medical Device Recall Event Report Form." Philips (China) is undertaking this recall to address the identified design or manufacturing issue and ensure patient safety and product reliability in accordance with regulatory expectations, highlighting its commitment to adhering to medical device safety standards under the NMPA's oversight.