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, as reported to the National Medical Products Administration (NMPA) on September 28, 2016. The primary issue identified was that the exposure termination warning sound, which signals the end of an X-ray exposure, could become inaudible if the monitor volume was set to "0." This design flaw poses a risk of users mistakenly believing an exposure did not occur, potentially leading to repeat exposures and unnecessary radiation for patients. While no injuries related to this problem have been reported, the company acted proactively to address the safety concern. The recall affects 125 units of various models and serial numbers distributed across China. As required actions, Philips Healthcare (Suzhou) Co., Ltd. has committed to notifying product users in writing through on-site safety notices and will implement an On-Site Corrective Action (FCO) to rectify the issue and ensure the warning sound functions consistently, irrespective of monitor volume settings.