# China NMPA Product Recall - Automated External Defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/cardiac-science-co-american-heart-science/9f8a3c0e-dc59-4f8f-a6f0-562cbf521ddf/
Source feed: China

> China NMPA product recall for Automated External Defibrillator by Cardiac Science Co. (American Heart Science) published August 31, 2010. Recall level: . The National Medical Products Administration (NMPA) issued a recall report on August 31, 2010, for F

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Event Report Form for Automated External Defibrillators
- Company Name: Cardiac Science Co. (American Heart Science)
- Publication Date: 2010-08-31
- Product Name: Automated External Defibrillator
- Recall Reason: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E and Responder 2023440 manufactured or repaired between October 19, 2009 and January 15, 2010 may not be able to provide therapeutic ice during emergency treatment, which could lead to serious adverse health events or death. Therefore, it has been decided to proactively replace these products.
- Discovering Company: American Heart Sciences
- Manufacturing Company: Cardiac Science Co. (American Heart Science)
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/cardiac-science-co-american-heart-science/414d236c-4eba-40d1-9473-d429c9cc6fcd/