# China NMPA Product Recall - Monitor/Defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/a1b435d6-6e91-4760-bc95-6697fb384336/
Source feed: China

> China NMPA product recall for Monitor/Defibrillator by Philips (China) Investment Co., Ltd. published July 01, 2019. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its HeartStart MRx Mo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. has initiated a voluntary recall of its Monitor/Defibrillator devices.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2019-07-01
- Product Name: Monitor/Defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: If the AC power module (model M3539A) of the HeartStart MRx monitor defibrillator fails, or if the main AC power supply to the HeartStart MRx monitor defibrillator is interrupted (due to failure to install the lithium-ion battery (model M3538A) according to the device instructions), the HeartStart MRx monitor defibrillator may lose all power and become inoperable. A failed AC power module may also fail to charge the battery. Simultaneous loss of both battery and AC power to the HeartStart MRx monitor defibrillator may result in interrupted monitoring or delays in the delivery of shocks or pacing therapy.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its HeartStart MRx Monitor/Defibrillator, as announced on July 1, 2019, by the National Medical Products Administration (NMPA). The recall stems from a critical issue identified with the AC power module (model M3539A). This module's failure can lead to the entire device becoming inoperable if the lithium-ion battery (model M3538A) is not properly installed according to device instructions, or if the AC mains power is interrupted. The primary concern is that a malfunctioning AC power module may not only fail to power the device but also be unable to charge the battery. Consequently, in situations where both battery power and AC power are simultaneously lost, patients could experience interruptions in monitoring or critical delays in receiving defibrillation shocks or pacing treatments. This poses a significant safety risk in emergency medical situations. Operating under the oversight of the NMPA, and registered with the Shanghai Food and Drug Administration, Philips (China) is taking this action to address the potential hazard. The company is recalling specific units of the HeartStart MRx Monitor/Defibrillator (Registration Certificate No.: 20163214004). Further comprehensive details regarding affected product models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form" provided by the company.

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