# China NMPA Product Recall - Monitor defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/d1555ce8-e217-458e-bd54-0f84c5a45a29
Source feed: China

> China NMPA product recall for Monitor defibrillator by Philips Medical Systems published January 27, 2015. Recall level: . Philips (China) Investment Co., Ltd. has initiated an expanded recall for its Monitored Defibrillato

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. expands recall of patient defibrillators
- Company Name: Philips Medical Systems
- Publication Date: 2015-01-27
- Product Name: Monitor defibrillator
- Recall Reason: The MRx may be affected by one or both of the following issues: 1. The CO2 inlet associated with the end-expiratory carbon dioxide (EtCO2) monitor on the MRx defibrillator may be pushed into the MRx housing, making it inaccessible. This may occur if the user attempts to push the CO2 FilterLine device into the inlet instead of turning it clockwise as described in the MRx User Manual. 2. The handle may detach from the MRx housing due to damage to the upper base of the rear cover.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd. has initiated an expanded recall for its Monitored Defibrillator (MRx) devices, as publicly reported by the National Medical Products Administration (NMPA) on January 27, 2015, based on Philips’ internal report dated January 6, 2015. The recall scope in China has been broadened to include an additional 16 units, bringing the total to 47 affected devices globally and within China. The primary issues necessitating this recall involve two critical product deficiencies affecting the MRx devices. Firstly, the CO2 inlet for the end-expiratory carbon dioxide (EtCO2) monitoring device may be susceptible to being pushed into the MRx housing, making it inaccessible if users attempt to force it rather than rotating it clockwise as per the instructions. Secondly, the device's handle may detach from the MRx housing due to damage to the upper base of the rear cover. In response to these significant product concerns and under the NMPA's regulatory guidance, Philips is implementing corrective actions. The company will provide a complimentary hardware upgrade for all identified affected devices. Philips representatives are actively contacting users of the affected units to arrange for the scheduling and installation of these essential hardware upgrades.

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