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

Philips (China) Investment Co., Ltd., on behalf of manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class III recall for two X-ray Computed Tomography (CT) Systems. Reported to the National Medical Products Administration (NMPA) on July 21, 2015, the recall addresses a critical manufacturing issue: a torque wrench failed its calibration, leading to incorrect torque application on the X-ray tube mounting hardware during installation. This could compromise the secure fastening of the X-ray tube. The affected units, identified as 75005 and 75006, were both imported and sold in China.

Despite no reported injuries globally related to this specific malfunction, Philips is taking comprehensive corrective actions. The company notified all affected users and issued Field Corrective Actions (FCOs). Philips Field Engineers will directly contact the affected customers to arrange for the replacement of the improperly torqued fasteners. This proactive measure ensures the CT systems operate safely and aligns with the regulatory requirements overseen by the NMPA, demonstrating Philips' commitment to product safety and quality standards.