China NMPA Product Recall - Semi-automatic external defibrillator

The National Medical Products Administration (NMPA) announced on March 17, 2021, a voluntary Class III recall initiated by Philips Medical Systems, specifically Philips (China) Investment Co., Ltd. The recall addresses an identified error in the serial number recording for certain models and batches of their semi-automatic external defibrillators. This issue affects devices registered under NMPA numbers 20183211860 and 20183211856. While the document does not mention specific inspection dates, the company proactively reported the discrepancy, leading to the voluntary recall action under the NMPA's regulatory oversight. The primary concern stems from inaccuracies in tracking device identification, which is critical for medical device management and patient safety. As a required action, Philips Medical Systems is recalling the affected devices. Further specific details regarding the impacted product models, specifications, and batch numbers are available in the accompanying 'Medical Device Recall Event Report Form' attachment. This recall underscores the importance of accurate data management in the medical device industry to maintain product integrity and ensure regulatory compliance.