China NMPA Product Recall - Automated External Defibrillator (AED)

Cardiac Science, Inc., in cooperation with its Chinese responsible unit, Cardiac Medical Equipment (Shanghai) Co., Ltd., has initiated a voluntary Level 1 recall of certain Automated External Defibrillator (AED) models. This action, published by the National Medical Products Administration (NMPA) on March 20, 2012, addresses a serious manufacturing defect from a supplier affecting circuit board components. The issue primarily impacts AEDs manufactured between July 1 and December 30, 2011. The critical defect poses a dual risk: affected devices may either accidentally induce defibrillation or be unable to deliver life-saving defibrillation treatment when needed. Although no first aid incidents related to this specific failure have been reported, the company identified the issue through its quality control processes. The recall extends to products in China and other countries. As a required action, affected AEDs are being returned to the manufacturer for prompt correction. The NMPA has also directed provincial food and drug administrations to strengthen supervision and management of these products to ensure patient safety and compliance. This proactive measure underscores a commitment to product integrity and public health protection.