# China NMPA Product Recall - Monitor/Defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/f075eaca-cbf0-4965-bc68-20d668fecc0e/
Source feed: China

> China NMPA product recall for Monitor/Defibrillator by Philips (China) Investment Co., Ltd. published March 11, 2020. Recall level: Level 2. Philips (China) Investment Co., Ltd. has initiated a voluntary Class II recall for its HeartStart MR

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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: 2020-03-11
- Product Name: Monitor/Defibrillator
- Recall Level: Level 2
- Recall Reason: This product is subject to internal damage if the HeartStart MRx monitor/defibrillator MRx is dropped or subjected to severe mechanical impact, even if there is no visible external damage to the device or the Ready-to-Use ("RFU") indicator on the device does not immediately display a fault. Unless the user performs a manual check immediately after the device is dropped or mishandled according to the procedures described in the instruction manual ("IFU"), the device will not immediately recognize the fault and will only alert the user to the problem during the next scheduled automatic self-test or operational check.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. has initiated a voluntary Class II recall for its HeartStart MRx monitor/defibrillator devices. This recall, reported on March 11, 2020, via the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a significant safety concern regarding device integrity.The core issue is that the HeartStart MRx may suffer internal damage from drops or severe mechanical impact, even without visible external damage or an immediate malfunction signal from the 'Ready-to-Use' indicator. A critical flaw is that the device will not immediately alert users to such internal damage, only flagging the problem during its next scheduled automatic self-test or operational check. This creates a safety risk unless the user performs an immediate manual check as per the instruction manual after any incident of dropping or mishandling.As a required action, Philips is recalling affected models, specifications, and batches of the monitor/defibrillator (Registration Certificate No.: 20163214004). The company urges users to strictly follow the instruction manual by manually inspecting the device immediately after any mechanical impact to ensure proper functionality and patient safety.

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