# China NMPA Product Recall - Monitor defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/5b33029c-b842-40cc-bbea-f6d187fedca6/
Source feed: China

> China NMPA product recall for Monitor defibrillator by Philips Medical Systems published December 12, 2014. Recall level: Level II. Philips (China) Investment Co., Ltd., in collaboration with the National Medical Products Administra

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls patient-controlled defibrillators.
- Company Name: Philips Medical Systems
- Publication Date: 2014-12-12
- Product Name: Monitor defibrillator
- Recall Level: Level II
- Recall Reason: The MRx may be affected by one or both of the following issues: 1. The air intake associated with the end-expiratory carbon dioxide (ECO2) 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 air intake 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. (Internal recall document number FCO 86100163)
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., in collaboration with the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration, initiated a voluntary Class II recall of specific Philips MRx Monitored Defibrillators. This action was officially announced on December 12, 2014, following a report dated November 18, 2014. The recall addresses two critical issues: the CO2 inlet on the end-expiratory carbon dioxide (EtCO2) monitoring device may be pushed into the defibrillator's housing, making it unusable, often due to incorrect user operation. Additionally, the device's handle may detach because of damage to the rear cover's upper base. The recall affects 31 units globally, all of which were imported and sold in China, encompassing models M3535A and M3538A. As a corrective action, Philips Medical Systems will provide a free hardware upgrade for all identified affected devices, with company representatives directly contacting users to arrange the installation of these essential improvements to ensure patient safety and device functionality.

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