# China NMPA Product Recall - Patient monitors (Models: Efficia CM10, CM100, CM12, CM120, CM150)

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-kincoway-shenzhen-industrial-co-ltd/e9b47fa6-3a9b-4f40-be5f-2e602312df1f/
Source feed: China

> China NMPA product recall for Patient monitors (Models: Efficia CM10, CM100, CM12, CM120, CM150) by Philips Kincoway (Shenzhen) Industrial Co., Ltd. published July 05, 2022. Recall level: Level 3 Recall. Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class III recall of several pati

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Kinco (Shenzhen) Industrial Co., Ltd. voluntarily recalls patient monitors
- Company Name: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Publication Date: 2022-07-05
- Product Name: Patient monitors (Models: Efficia CM10, CM100, CM12, CM120, CM150)
- Recall Level: Level 3 Recall
- Recall Reason: When the Efficia CM.FPGA component malfunctions, the detection parameter values may disappear.
- Discovering Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Manufacturing Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Summary: Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class III recall of several patient monitor models, including Efficia CM10, CM100, CM12, CM120, and CM150. This action, publicly announced on July 5, 2022, was prompted by internal monitoring that revealed a potential malfunction in the Efficia CM. FPGA component. This issue could lead to the disappearance of crucial detection parameter values during operation, potentially impacting patient care. The recall addresses a critical product performance issue under the oversight of the National Medical Products Administration (NMPA). Philips Kinco is responsible for implementing the necessary corrective actions to ensure the safety and reliability of its medical devices, aligning with regulatory expectations for medical device quality and post-market surveillance. Detailed information on affected product batches is available in the associated "Medical Device Recall Event Report Form".

Company: https://www.globalkeysolutions.net/companies/philips-kincoway-shenzhen-industrial-co-ltd/fe26b37f-e114-43d2-b1a3-85beed6a47a7/