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

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall of its Digital Medical X-ray Imaging Systems, specifically the DuraDiagnost model. This action was reported on April 1, 2017, and published by the National Medical Products Administration (NMPA) on June 5, 2017. The recall impacts 98 units manufactured or imported into China, in addition to products distributed across several international markets including the USA, UK, and Germany.

The critical issue identified is the potential for cracking at the weld points of the X-ray tube assembly's vertical motion support. This structural flaw could cause abnormal displacement or off-centering of the X-ray tube arm, with the severe risk of the entire assembly detaching. Fortunately, no injuries have been reported to date related to this defect.

Operating under the NMPA's regulatory guidance, Philips Healthcare (Suzhou) is executing a Field Corrective Action (FCO). The company will issue field safety notices to affected users and deploy after-sales service engineers to implement corrective measures. These actions involve inspecting the compromised weld points and installing a new safety locking structure to guarantee the X-ray tube assembly remains secure, even if the primary weld points fail, thereby upholding patient and operator safety.