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

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall of its Digital Medical X-ray Imaging Systems (Registration No.: 20132301545) in China, as overseen by the National Medical Products Administration (NMPA). Announced on December 23, 2016, the recall addresses an issue where the exposure termination warning sound becomes inaudible if the monitor volume is set to zero. This defect presents a risk of unnecessary patient radiation exposure, as users might mistakenly believe an exposure failed and re-expose the patient. The recall impacts 30 units of the Primary Diagnost DR system, identified by specific product numbers ranging from SN160033 to SN160070. Philips Healthcare (Suzhou) Co., Ltd. has confirmed that no injuries have been reported in connection with this issue. The required actions include notifying affected users through a field safety notice and implementing a Field Corrective Action (FCO) to rectify the problem in all impacted devices.