China NMPA Product Recall - Automated External Defibrillator

The National Medical Products Administration (NMPA) issued a recall report on August 31, 2010, for Fully Automated External Defibrillators manufactured by Cardiac Science Co., with Cardiac Medical Equipment (Shanghai) Co., Ltd. as the responsible unit in China. The recall pertained to specific Powerheart models, notably 24 units of Powerheart 9300E imported to mainland China, manufactured or repaired between October 19, 2009, and January 15, 2010.

The core issue, discovered in February 2010 via internal quality control, was a potential failure of the devices to provide therapeutic energy during emergency treatment due to missed self-inspection checks. This defect carried a risk of serious adverse health events or death. While the malfunction rate of 1 in 75,000 met US FDA Class 3 product requirements, the company proactively initiated a recall.

Cardiac Science promptly reported the issue to the US Food and Drug Administration (FDA) for collaborative research and improvement, with the FDA updating its recall information on April 27, 2010. In China, the responsible unit immediately froze sales of affected products. All 24 Powerheart 9300E units in China were confirmed unsold in warehouses and were returned to the US headquarters by March 2010. The company committed to establishing a direct reporting system for future quality information and market feedback, ensuring compliance with global regulatory standards.