China NMPA Product Recall - Digital medical X-ray imaging system

Philips Medical Systems DMC GmbH initiated a voluntary recall of its Digital Medical X-ray Imaging System, as reported by Philips (China) Investment Co., Ltd. to the National Medical Products Administration (NMPA) on September 30, 2014. The recall was prompted by a critical safety non-conformance: the protective grounding wire within the EM-Cabinet modular X-ray architecture (CXA) wall box failed to meet the specified external wiring dimensions. This issue violated Canadian requirement CAN/CSA-C22.2 No. 0.4, concerning the "Impedance Bonding Test for Electrical Equipment," indicating a potential electrical safety risk.

Philips Medical Systems DMC GmbH, the manufacturer, along with its responsible unit in China, Philips (China) Investment Co., Ltd., confirmed that the specific affected product batches, identified by Registration Certificate No.: CFDA (Imported) No. 20123304584, were neither imported into nor sold within the Chinese market. Consequently, no direct corrective actions were required for products in China. The NMPA document, published on October 10, 2014, emphasized the importance for regional food and drug administrations to enhance supervision and management of similar medical devices to ensure public safety. This proactive recall demonstrates the company's adherence to international safety standards, even for products not distributed in a particular market.