# China NMPA Product Recall - Semi-automatic external defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/d65ad33a-d0b7-4c14-9a62-1d9e447a576f/
Source feed: China

> China NMPA product recall for Semi-automatic external defibrillator by Philips Medical Systems published October 31, 2018. Recall level: Level 2 Recall. Philips Medical Systems, in collaboration with Philips (China) Investment Co., Ltd., initiated a vol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems initiates voluntary recall of semi-automated external defibrillators.
- Company Name: Philips Medical Systems
- Publication Date: 2018-10-31
- Product Name: Semi-automatic external defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: The recalled semi-automatic external defibrillators may not meet their IPx5 waterproof rating.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems, in collaboration with Philips (China) Investment Co., Ltd., initiated a voluntary Class II recall of specific semi-automatic external defibrillators, a measure formally reported to the National Medical Products Administration (NMPA) on September 30, 2018, with public notification on October 31, 2018. This action addresses a critical quality concern: the potential failure of the devices to meet their specified IPx5 waterproof performance. Such a non-compliance could compromise the device's reliability in emergency medical situations, where it is vital for patient safety. The affected defibrillators, identified by National Medical Device Registration Certificate 20153213377, comprise models 861388 and 861389, manufactured between October 2016 and February 2017. These devices are designed for emergency use by trained personnel to treat ventricular fibrillation and tachycardia, provide CPR guidance, and offer non-diagnostic ECG displays for patients over 25 kg or using an "Infant/Child Key" for younger patients. The recall's scope is global, emphasizing the seriousness of the potential defect. However, it is important to note that the specific batches identified as potentially non-compliant were not distributed or sold within the Chinese market. Consequently, the Chinese regulatory framework did not necessitate specific local corrective actions or handling methods for these particular units. This proactive recall demonstrates Philips' commitment to product quality and patient safety on an international scale, under the oversight of regulatory bodies like the NMPA.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47/