China NMPA Product Recall - X-ray computed tomography system

Philips Medical Systems Nederland B.V. initiated a voluntary Class III recall of its Computed Tomography Systems following an issue identified with the SynchRight P3T (Personalized Patient Protocol) software. This recall was reported by Philips (China) Investment Co., Ltd. and published by the National Medical Products Administration (NMPA) on June 30, 2021. The core problem involves the SynchRight P3T software inaccurately increasing a patient's weight when the measurement unit is set to pounds. This software anomaly could potentially lead to incorrect dosage or treatment protocols, posing a risk to patient safety. The affected products are specific models and batches of Computed Tomography Systems, including those with Registration Certificate Nos. 20153060422, 20173302330, and 20163061984. Philips Medical Systems Nederland B.V. is proactively addressing this critical software defect by withdrawing the affected devices from the market. A Class III recall indicates that the product defect is unlikely to cause adverse health consequences but warrants corrective action to prevent potential patient harm. Detailed information about specific models and batches is provided in an accompanying Medical Device Recall Event Report Form. The company's voluntary action under the NMPA framework highlights a commitment to product safety and regulatory compliance.