China NMPA Product Recall - EPIQ7 Color Doppler Ultrasound Diagnostic System

Philips (China) Investment Co., Ltd., in conjunction with its manufacturer Philips Ultrasound, Inc., initiated a voluntary global recall for its EPIQ7 Color Doppler Ultrasound Diagnostic System on April 22, 2015. This action stemmed from a identified software conversion error within the system. The critical issue manifests when the ultrasound system is set to "Metric" units, resulting in incorrect calculations of a patient's body surface area (BSA) upon the entry of weight and/or height data. While no patient injuries have been reported globally related to this defect, the potential for inaccurate diagnostic information based on erroneous BSA values prompted the recall. Operating under the regulatory oversight of the National Medical Products Administration (NMPA), Philips has actively informed all affected users and implemented a formal Field Corrective Action (FCO). As part of this corrective measure, Philips' field service engineers are contacting impacted customers to schedule and perform essential software updates. This process aims to rectify the calculation error, ensuring the accurate determination of BSA and maintaining diagnostic reliability. The recall specifically affects 36 units imported into China.