# China NMPA Product Recall - MX400/MX450/MX500/MX550 Patient Monitors

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medizin-systeme-boeblingen-gmbh/e961bd57-7c4e-4f2e-89d3-fd6289eb51dd/
Source feed: China

> China NMPA product recall for MX400/MX450/MX500/MX550 Patient Monitors by Philips Medizin Systeme Boeblingen GmbH published September 30, 2016. Recall level: Level II. Philips (China) Investment Co., Ltd. has voluntarily initiated a Class II recall for its MX400, MX45

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls patient monitors
- Company Name: Philips Medizin Systeme Boeblingen GmbH
- Publication Date: 2016-09-30
- Product Name: MX400/MX450/MX500/MX550 Patient Monitors
- Recall Level: Level II
- Recall Reason: If a patient monitor has been continuously powered on for several months without being turned off or restarted, it may be affected, resulting in a lag in the displayed waveforms, thus failing to reflect the patient's real-time condition. Although this issue will cause the display to lag, the monitor's alarm and vital sign readings will function normally and accurately reflect the patient's real-time data. The length of continuous power-on time before this problem occurs will vary depending on the waveform display speed selected: 102 days (@50mm/s) to 820 days (@6.25mm/s); 205 days (@25 mm/s default waveform speed). The monitor must be turned off to avoid this problem; simply putting it in standby mode is insufficient.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medizin Systeme Boeblingen GmbH
- Summary: Philips (China) Investment Co., Ltd. has voluntarily initiated a Class II recall for its MX400, MX450, MX500, and MX550 patient monitors. Reported to the National Medical Products Administration (NMPA) on July 27, 2016, and published on September 30, 2016, the recall addresses a critical issue where continuous operation for several months without restarting can cause displayed waveforms to lag, failing to reflect the patient's real-time condition. While essential alarm functions and numerical vital sign displays remain accurate, the waveform visualization becomes unreliable. The timeframe before this issue manifests ranges from 102 to 820 days, depending on the waveform display speed, with approximately 205 days at the default setting. As a corrective action, Philips is issuing Field Safety Notices globally and will provide free software upgrades to all affected customers. Users are advised that simply placing the monitor in standby mode is insufficient; a complete power cycle is required to prevent the waveform lag.

Company: https://www.globalkeysolutions.net/companies/philips-medizin-systeme-boeblingen-gmbh/0835e871-fa13-4c6d-a7fd-379646136ce0/