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

Philips (China) Investment Co., Ltd., in conjunction with manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class III recall of specific X-ray Computed Tomography (CT) Systems. This recall was reported to the National Medical Products Administration (NMPA) on June 7, 2016, and publicly announced on August 29, 2016. The core issue centers on a defect in the back cover of the CT system's scanning table. Specifically, the area around the Philips logo on the back sub-frame cover may lack sufficient structural integrity, making it prone to cracking under normal operation or if subjected to excessive force from medical delivery equipment or accessories. This defect poses a potential risk of cuts or lacerations to operators, patients, caregivers, or service personnel. No injuries have been reported to date. In response, Philips has issued a Field Corrective Action (FCO) and directly notified all affected users. The company's field engineers are responsible for contacting customers to facilitate the replacement of the compromised back covers on all identified affected units, which include models such as Brilliance ICT and Ingenuity CTO.