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 December 15, 2016, and publicly announced on December 23, 2016. The recall addresses two critical technical issues. The first involves an internal firmware anomaly in the Pixium 4343RG flat panel detector, which can intermittently cause the system to incorrectly display readiness for image acquisition, resulting in failed X-ray exposures. The second issue pertains to the exposure termination prompt sound; if the monitor volume is set to zero, users may not hear this essential alert, potentially leading to unnecessary patient re-exposure due to the belief that the initial exposure failed. Although these issues could impact diagnostic accuracy or increase patient radiation, no injuries have been reported. Under the NMPA's regulatory framework, Philips Healthcare (Suzhou) Co., Ltd. has taken required actions by notifying affected customers via a field safety notice and will implement a Field Corrective Action (FCO). Philips after-sales service engineers will provide a free software upgrade package to resolve the firmware and audio notification issues for all affected units, including 61 devices in China and others distributed globally.