# China NMPA Product Recall - Patient monitors (IntelliVue X2, IntelliVue MP2, IntelliVue MP5)

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/a7954020-a609-47cb-890c-9babd3604c91/
Source feed: China

> China NMPA product recall for Patient monitors (IntelliVue X2, IntelliVue MP2, IntelliVue MP5) by Philips (China) Investment Co., Ltd. published April 23, 2021. Recall level: Level 3 Recall. On April 23, 2021, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for s

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling patient monitors.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-04-23
- Product Name: Patient monitors (IntelliVue X2, IntelliVue MP2, IntelliVue MP5)
- Recall Level: Level 3 Recall
- Recall Reason: The issue concerns the IntelliVue X2 patient monitor (model M3002A), the IntelliVue MP2 patient monitor (model M8102A), and the IntelliVue MP5 patient monitor (models M8105A/M8105AS). The software version number K of these monitors does not match the description in the product registration standard, although the product standard itself complies with the registration technical standards. Furthermore, this issue does not pose a safety risk to patients.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On April 23, 2021, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for specific patient monitor models. This action was reported through the Shanghai Municipal Drug Administration website, operating under the regulatory oversight of the National Medical Products Administration (NMPA). The core issue identified was that the software version 'K' of certain IntelliVue X2 (model M3002A), IntelliVue MP2 (model M8102A), and IntelliVue MP5 (models M8105A/M8105AS) patient monitors did not precisely match the description in their respective product registration standards. Philips clarified that while the software description was inconsistent, the product's technical standard remained compliant, and crucially, this discrepancy poses no safety risk to patients. As a required action, Philips (China) Investment Co., Ltd. is voluntarily recalling these affected patient monitors, including devices with Registration Certificate Nos.: 20163071924, 20163070388, and 20163071923. Comprehensive details concerning the specific models, specifications, and batches are provided in the accompanying "Medical Device Recall Event Report Form." This recall underscores the company's commitment to maintaining accuracy in product documentation, even for issues without direct patient safety implications.

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