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

Philips Healthcare (Suzhou) Co., Ltd. initiated a Class III voluntary recall of its Digital Medical X-ray Imaging Systems, including models such as DigitalDiagnost Power and DigitalDiagnost Pro. This recall was reported to the National Medical Products Administration (NMPA) on June 23, 2017, and subsequently published on July 19, 2017. The core issue stems from an internal firmware malfunction in the Pixium 4343RC fixed flat panel detector. This defect causes the system to incorrectly signal readiness for image acquisition, potentially leading to a failure in correctly capturing X-ray exposure images. The recall impacts 109 units sold in China, with broader distribution across Australia and New Zealand, all designated for clinical X-ray imaging diagnosis. While the malfunction could affect diagnostic capabilities, no related injuries have been reported to date. To resolve this, Philips plans to provide a complimentary software upgrade for all affected systems. Philips after-sales service engineers will proactively contact customers to arrange and implement the necessary corrective software update.