China NMPA Product Recall - Color Doppler Ultrasound Diagnostic System; Color Doppler Ultrasound Diagnostic System; Color Doppler Ultrasound Diagnostic System and Transducers; Color Doppler Ultrasound Diagnostic System; Color Doppler Ultrasound Diagnostic System; Color Doppler Ultrasound Diagnostic System

Philips (China) Investment Co., Ltd. has initiated a voluntary Class II recall for multiple models of its Color Ultrasound Diagnostic Systems, as publicly reported on March 23, 2021. The decision stems from Philips' recent discovery that these devices may display and subsequently save incorrect patient data when utilized in certain uncommon workflows. Further complicating the issue, different software versions of the affected systems reportedly exhibit varying symptoms related to this data integrity problem, identified internally as FCO79500532. The recall specifically targets color ultrasound diagnostic systems holding several registration certificate numbers, including 20193061914, 20193061919, 20153061350, 20183230036, 20153061349, and 20193062262. This significant regulatory measure is being overseen by the National Medical Products Administration (NMPA), with information disseminated through the Shanghai Municipal Drug Administration. Philips' required action involves systematically recalling all affected medical devices to mitigate the risk of patient information inaccuracies and ensure compliance with medical device regulations. This proactive recall demonstrates a commitment to patient safety and data reliability.