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

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall for its Digital Medical X-ray Imaging Systems, including models like DuraDiagnost and DuraDiagnost 50SE. The recall was publicly reported on July 8, 2016, stemming from a company report on June 27, 2016. The primary concern is a design flaw allowing the exposure warning sound, which indicates the completion of an X-ray, to be set to '0' volume. If muted, users would not hear the crucial beep, potentially leading them to mistakenly believe the exposure was incomplete and prompting unnecessary patient re-exposure to radiation. No patient injuries linked to this issue have been reported to date.

Operating under the regulatory guidance of the National Medical Products Administration (NMPA) in China, Philips Healthcare (Suzhou) Co., Ltd. has outlined specific corrective actions. The company has proactively notified affected product users through written on-site safety notices. The required action involves implementing an On-Site Corrective Action (FCO71200155) to resolve the identified audio notification deficiency in the affected devices. The recall affects 153 manufactured units, with 40 units distributed within China, and a significant number spread across multiple international markets.