# China NMPA Product Recall - Digital medical X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/2a305ffc-962d-45c4-9c2f-5039257eb4c7/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Philips Healthcare (Suzhou) Co., Ltd. published November 28, 2017. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall for 29 units of its Dig

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Healthcare (Suzhou) Co., Ltd. voluntarily recalls digital medical X-ray imaging systems
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Publication Date: 2017-11-28
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: Incorrect labeling on vertical camera stand
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall for 29 units of its Digital Medical X-ray Imaging Systems in China. This recall was reported to the National Medical Products Administration (NMPA) on November 27, 2017, with the announcement published the following day. The primary issue identified was an incorrect label affixed to the vertical imaging gantry, where a "BuckyDiagnost VS Label" was mistakenly used instead of the proper "Vertical Stand 2 Label." This labeling error affected various DigitalDiagnost models, including the 65ER, 80ER, 65EN, 80EN, 80PR, 65PN, and 80PN variants, which are registered under certificate number Su Medical Device Registration Certificate 20162300868.

In response to this regulatory framework, Philips Healthcare (Suzhou) Co., Ltd. is undertaking free on-site corrective measures (FCO71200183) to replace all incorrect vertical stand labels with the accurate ones on the affected devices. As a Class III recall, the issue is considered to have a low probability of causing adverse health consequences, but the company is ensuring compliance and accurate product identification for medical devices used in clinical X-ray imaging diagnosis.

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