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, reported to the National Medical Products Administration (NMPA) on June 23, 2017, and publicly announced on July 18, 2017. The recall affects models including DigitalDiagnost Power, DigitalDiagnost Power 80, and DigitalDiagnost Pro, used for clinical X-ray imaging. The core issue stems from an internal firmware malfunction within the Pixium 4343RC fixed flat panel detector. This defect causes the detector to intermittently display as ready for image acquisition when it is not, leading to potential failures in correctly acquiring X-ray exposure images. While no injuries have been reported, this issue requires corrective action under the NMPA's regulatory oversight, referencing specific medical device approval numbers. Philips Healthcare (Suzhou) Co., Ltd. will resolve the problem by providing a free software upgrade for all affected systems. Their after-sales service engineers will proactively contact customers in impacted regions, including China, Australia, and New Zealand, to schedule and implement the necessary software installation. A total of 123 units were manufactured, with 109 units sold in China.