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

Philips Medical (Suzhou) Co., Ltd., also identified as Philips Healthcare (Suzhou) Co., Ltd., initiated a voluntary Class III recall for its Digital Medical X-ray Imaging Systems, specifically models within the DuraDiagnost series. This action, reported to the National Medical Products Administration (NMPA) on May 5, 2016, and publicly announced on August 30, 2016, addresses a critical internal firmware malfunction in the Pixium 4343RG flat panel detector. The primary issue is the system's intermittent and incorrect display of readiness for image acquisition, which can lead to the failure of X-ray exposure image capture. Fortunately, no patient injuries have been reported as a result of this anomaly.

The recall falls under the regulatory purview of the NMPA. To rectify the problem, Philips is implementing a Field Corrective Action (FCO71200131). The company has already issued field safety notices to users and will dispatch its after-sales service engineers. These engineers are tasked with providing a complimentary software upgrade to all 55 affected units globally, including 10 units distributed in China, once the necessary software package becomes available. This measure aims to resolve the firmware issue, ensuring the continued safe and accurate operation of these medical devices.