# China NMPA Product Recall - Mobile digital medical X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/0ea78091-2b23-443a-8cd3-53cb84d4292f
Source feed: China

> China NMPA product recall for Mobile digital medical X-ray imaging system by Philips Healthcare (Suzhou) Co., Ltd. published March 11, 2020. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall for its Mobile Digital 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Healthcare (Suzhou) Co., Ltd. has initiated a voluntary recall of its mobile digital medical X-ray imaging system.
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Publication Date: 2020-03-11
- Product Name: Mobile digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: The product only has an English instruction label affixed. According to GB7247.1-2012, a Chinese instruction label should also be affixed.
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall for its Mobile Digital Medical X-ray Imaging System, effective March 11, 2020. This critical action, reported to China's National Medical Products Administration (NMPA), arose from internal testing that revealed a significant non-compliance: the manufactured devices, including models such as M5032, were found to be missing the mandatory Chinese instruction labels. This directly violates the requirements stipulated in the GB7247.1-2012 standard, which governs such medical devices. The recall encompasses 28 units sold across China, identified by various serial numbers ranging from SN170001 to SN190004. Philips confirmed that, as of the recall date, no complaints of injury attributed to this specific labeling issue had been received. In response, Philips Healthcare (Suzhou) Co., Ltd. is actively notifying all affected users. Furthermore, company field engineers are scheduled to contact customers directly to provide on-site support and comprehensive instructions pertaining to the product's English laser documentation, thereby rectifying the identified labeling deficiency and ensuring regulatory adherence.

Company: https://www.globalkeysolutions.net/companies/philips-healthcare-suzhou-co-ltd/f697ee6b-76f7-4128-9e8c-71e7ebe08572