# China NMPA Product Recall - Semi-automatic external defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/physio-control-inc/46ee482c-43b2-4416-8b4a-e141203e02cc/
Source feed: China

> China NMPA product recall for Semi-automatic external defibrillator by Physio-Control, Inc. published December 01, 2017. Recall level: Level 2. Physio-Control, Inc. initiated a voluntary Class III recall for specific batches of its semi-automat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Physio-Control, Inc. Active Recall of Semi-Automatic External Defibrillators
- Company Name: Physio-Control, Inc.
- Publication Date: 2017-12-01
- Product Name: Semi-automatic external defibrillator
- Recall Level: Level 2
- Recall Reason: Physio-Control, Inc. has discovered that illustrations on the packaging of certain batches of its low-energy infant defibrillator pads do not conform to Physio-Control specifications, and that the electrode placement for infants is incorrectly indicated. The affected low-energy infant defibrillator electrodes are not defective in performance or function; the issue is limited to illustrations on the electrode pads within the packaging showing incorrect electrode placement for infants. No related customer complaints have been reported.
- Discovering Company: Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd.
- Manufacturing Company: Physio-Control, Inc.
- Summary: Physio-Control, Inc. initiated a voluntary Class III recall for specific batches of its semi-automatic external defibrillators (NMPA Registration No. 20163212101). This recall, reported by its agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., on November 22, 2017, and published by the National Medical Products Administration (NMPA) on December 1, 2017, addresses a packaging discrepancy. The primary issue is an incorrect illustration on the packaging of low-energy infant defibrillator electrode pads, depicting an improper electrode placement for infants. Critically, the performance or function of the affected defibrillators and electrodes remains unimpaired, with the problem strictly limited to the misleading diagram. No adverse event reports or customer complaints have been received regarding this issue. Operating under the NMPA regulatory framework, the company's required actions include a comprehensive recall. This entails ceasing the use of the affected low-energy infant defibrillator electrodes and implementing procedures for their retrieval and destruction. The recall impacts models such as the low-energy infant defibrillator electrode 11101-000016, with 30 units in China bearing affected identification information like batch numbers 713609 and 717912. This global recall aims to prevent potential user errors due to the incorrect visual guidance, ensuring patient safety.

Company: https://www.globalkeysolutions.net/companies/physio-control-inc/3f3fead7-44b0-4898-8ff3-0df0a9625a62/