China NMPA Product Recall - Medical diagnostic X-ray system

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its medical diagnostic X-ray systems, as reported by the National Medical Products Administration (NMPA) on January 6, 2020. This action addresses two significant technical issues that could impact patient or user safety. The first, termed "Error 80," involves a malfunction in the examination bed's tilt and vertical movement, causing it to lock in position and necessitating professional intervention. The second issue concerns the System Power Distribution Unit (SPDU), where thermal switches, crucial for preventing overheating in the main power supply, may be incorrectly installed and prone to malfunction. While these problems were identified through internal monitoring and complaints, Philips confirmed that no related patient injuries have been reported globally. The recall, overseen by regulatory bodies like the NMPA and Shanghai Municipal Drug Administration, requires Philips to retrieve affected products (Registration Certificate No.: 20182300210). Specific details regarding affected models and batches are available in the accompanying Medical Device Recall Event Report Form, ensuring corrective action for potentially impacted devices.