# China NMPA Product Recall - Monitor defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/f0623188-e87d-445a-b87d-0c986cb07094/
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., on January 6, 2015, issued an expanded recall for its Monitore

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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 contain incorrect internal software settings, leading to the following two problems: 1. The device will perform automatic weekly tests hourly, which can cause the treatment capacitors to degrade faster than expected. 2. When the device is connected to AC or DC power and no batteries are installed, or when the installed batteries have less than 10% charge on an AC or DC power supply, the Ready-to-Use (RFU) indicator will not provide the expected low battery indication (flashing red X light and audible chirping). Instead, the RFU will display a black hourglass symbol, indicating sufficient battery power for device operation.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., on January 6, 2015, issued an expanded recall for its Monitored Defibrillators, models M3535A and M3536A, under the oversight of the National Medical Products Administration (NMPA) in China. This action stemmed from the identification of incorrect internal software settings affecting devices, including an additional unit brought into the recall scope. The primary issues identified were twofold: firstly, affected devices performed an automatic weekly test every hour, leading to accelerated degradation of the treatment capacitors. Secondly, the Ready-to-Use (RFU) indicator failed to accurately display a low battery warning when connected to AC or DC power with an absent or low-charge battery. Instead, it showed a misleading symbol suggesting sufficient power, potentially compromising device readiness. Philips is undertaking corrective actions for all identified units free of charge. These actions include replacing the treatment capacitors and resetting the internal software settings to rectify the issues. Philips representatives are in the process of contacting affected users to coordinate and facilitate these essential repairs, ensuring patient safety and device reliability.

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