China NMPA Product Recall - Digital mammography machine

Philips (China) Investment Co., Ltd., representing manufacturer Philips Medical Systems DMC GmbH, initiated a Class II voluntary recall for specific Digital Mammography Machines (MultiDiagnost Eleva FD, serial number 228). This action was reported to the National Medical Products Administration (NMPA) on January 21, 2015, after Philips identified intermittent software license key failures. The company's internal testing and customer complaints, handled in accordance with standards like 21 CFR 1003.2(b)(1), revealed two main issues. Firstly, the license key for the spectrometer filter occasionally failed to load, resulting in the low mode reference air kerma rate being higher than expected during patient positioning, potentially increasing patient dose for short durations. Secondly, the license key for the full bed tilt range intermittently failed, restricting the bed's movement from the intended -90° to 90° range to -20° to 90°, thereby preventing certain image mappings. Philips confirmed only two customer complaints and no reported injuries related to these malfunctions. As a corrective action, Philips will deploy field service engineers to install software version R6.1.3 on affected devices to resolve the license key loading issues.