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

Philips Medical (Suzhou) Co., Ltd. initiated a Class III voluntary recall of its Digital Medical X-ray Imaging Systems, as reported by the National Medical Products Administration (NMPA) on July 18, 2017. The recall, first reported by Philips on June 1, 2017, addresses a critical safety concern: the potential cracking of weld points on the vertical motion support of the X-ray tube assembly. This defect could lead to abnormal displacement of the X-ray tube arm or, in severe cases, the complete detachment and falling of the X-ray tube assembly. While no injuries have been reported to date, the issue poses a significant safety risk to patients and operators.

Under the NMPA's regulatory framework for medical device recalls, Philips Medical (Suzhou) Co., Ltd. is mandated to undertake specific corrective actions. The company will issue a field safety notice to affected users and implement a Field Corrective Action (FCO). This action involves trained after-sales service engineers inspecting the weld points of the X-ray tube's vertical motion support and installing a new safety locking structure. This enhancement aims to prevent the X-ray tube assembly from falling, even if the primary weld points fail. The recall affects 98 units globally, including products distributed across numerous countries such as the USA, UK, Germany, and China.