# China NMPA Product Recall - HeartStart XL Defibrillator/Monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/6ae67644-1b74-495a-af22-3fbf94071f73/
Source feed: China

> China NMPA product recall for HeartStart XL Defibrillator/Monitor by Philips (China) Investment Co., Ltd. published May 20, 2020. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a Class II voluntary recall of its HeartStart XL defi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. has initiated a voluntary recall of defibrillators.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2020-05-20
- Product Name: HeartStart XL Defibrillator/Monitor
- Recall Level: Level 2 Recall
- Recall Reason: The product is discontinued, spare parts are unavailable, and the product has exceeded its service life. Continued use may cause the energy selection knob switch to malfunction, resulting in the device failing to turn on, failing to perform the selected function, or providing inaccurate shock energy levels, potentially leading to treatment delays or failure to deliver the intended treatment.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a Class II voluntary recall of its HeartStart XL defibrillator/monitor, as announced by the National Medical Products Administration (NMPA) on May 20, 2020. The recall addresses ongoing use of devices discontinued in February 2013, for which repair parts became unavailable in December 2018. Despite exceeding their service life, Philips discovered some customers were still utilizing these defibrillators. Continued operation of these outdated units presents a risk of malfunction in the energy selection knob switch, potentially leading to device failure to power on, inability to perform selected functions, or delivery of an incorrect energy level shock. These issues could result in delayed or ineffective patient treatment. Philips (China) is taking this action to mitigate the potential for unexpected device behavior once the product has surpassed its intended operational lifespan. Further details regarding the specific affected product models and batches are available in the associated Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/