China NMPA Product Recall - Mobile digital medical X-ray imaging system

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall for its Mobile Digital Medical X-ray Imaging System, effective March 11, 2020. This critical action, reported to China's National Medical Products Administration (NMPA), arose from internal testing that revealed a significant non-compliance: the manufactured devices, including models such as M5032, were found to be missing the mandatory Chinese instruction labels. This directly violates the requirements stipulated in the GB7247.1-2012 standard, which governs such medical devices. The recall encompasses 28 units sold across China, identified by various serial numbers ranging from SN170001 to SN190004. Philips confirmed that, as of the recall date, no complaints of injury attributed to this specific labeling issue had been received. In response, Philips Healthcare (Suzhou) Co., Ltd. is actively notifying all affected users. Furthermore, company field engineers are scheduled to contact customers directly to provide on-site support and comprehensive instructions pertaining to the product's English laser documentation, thereby rectifying the identified labeling deficiency and ensuring regulatory adherence.