# China NMPA Product Recall - Monitor defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/2f3321fb-642b-4a3d-a56c-349faae3cf3c
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. initiated a voluntary Class II recall of specific monitored def

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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 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 are less than 10% charged 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. initiated a voluntary Class II recall of specific monitored defibrillator models (M3535A, M3536A) in December 2014, as reported to the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration. The recall was prompted by internal software defects identified on November 18, 2014.
The primary issues stemmed from faulty software settings. Firstly, affected devices performed an automatic weekly test every hour, accelerating the degradation of treatment capacitors. Secondly, when connected to AC or DC power with no battery or a critically low battery charge (less than 10%), the Ready-to-Use (RFU) indicator would misleadingly display a black hourglass symbol, suggesting adequate power, rather than the expected low battery alert (flashing light and audio chirp). While other battery indicators functioned, this specific RFU anomaly posed a significant safety concern regarding device readiness.
To address these critical malfunctions, Philips committed to providing free corrective actions for all affected devices globally, including 3 units imported to China. These actions involve replacing the compromised treatment capacitors and resetting the internal software settings. Philips representatives are actively contacting affected users to schedule and facilitate the necessary repairs, ensuring the devices return to their intended operational safety and reliability standards.

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