# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/ce4ae8a6-0d38-4755-90cb-cbd2b0143ec5/
Source feed: China

> China NMPA product recall for Patient monitor by Philips (China) Investment Co., Ltd. published October 11, 2017. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall of specific patient monit

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls patient monitors
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2017-10-11
- Product Name: Patient monitor
- Recall Level: Level 2 Recall
- Recall Reason: When certain technical alarm messages are triggered due to mechanical damage or liquid inflow into the product, the ECG filter may be automatically activated, resulting in inaccurate true and ST values in the 12-lead ECG.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall of specific patient monitor models on October 11, 2017, as reported by the National Medical Products Administration (NMPA). The recall addresses a critical product issue where the patient monitors, registered under CFDA (Imported) 2014 No. 3214509, CFDA (Imported) 2014 No. 3214508, and CFDA 2012 No. 3214099, may automatically activate an ECG filtering function. This activation occurs when certain technical alarm messages are triggered, often due to mechanical damage or liquid ingress. The primary concern is that this automatic filtering can lead to inaccurate ST values in the 12-lead electrocardiogram (ECG) readings, potentially compromising patient diagnosis and care. This proactive measure by Philips (China) Investment Co., Ltd. aligns with medical device safety regulations overseen by the NMPA, ensuring the integrity and reliability of medical equipment in clinical settings. Detailed information on affected product batches and specifications is available in the "Medical Device Recall Event Report Form" associated with NMPA Index No. JGXX-2017-10939.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/