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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/1523a94a-17a1-47e1-a46b-df6f8e27cc52/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Philips Healthcare (Suzhou) Co., Ltd. published July 19, 2017. Recall level: Level 3 Recall. Philips Medical (Suzhou) Co., Ltd. initiated a voluntary Level III recall, formally published by the

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## 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: 2017-07-19
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: Based on user feedback, Philips discovered a potential cracking issue at the weld points of the X-ray tube assembly's vertical motion support. Cracks at these weld points could cause abnormal displacement of the X-ray tube arm, leading to the tube deviating from its center. If all weld points crack, the X-ray tube assembly could fall off.
- Discovering Company: Philips Healthcare Co., Ltd. (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Medical (Suzhou) Co., Ltd. initiated a voluntary Level III recall, formally published by the National Medical Products Administration (NMPA) on July 19, 2017, for several models of its Digital Medical X-ray Imaging Systems. This action followed a report dated June 1, 2017, detailing a critical safety concern. The primary issue identified was the potential for cracking at the weld points of the vertical motion support within the X-ray tube assembly. This defect could lead to abnormal displacement and off-centering of the X-ray tube arm, with a severe risk of the entire assembly falling if all weld points fail. Although no related injuries have been reported, the potential for serious harm necessitated immediate intervention. Operating under the NMPA's regulatory guidance, Philips is implementing comprehensive corrective measures. The company is notifying affected users globally through field safety notices and issuing a Field Corrective Action (FCO). These actions include after-sales service engineers conducting on-site inspections of the X-ray tube's vertical motion support weld points. Crucially, a new safety locking structure will be installed to ensure the X-ray tube assembly remains secure, even in the event of weld point cracking, thereby significantly enhancing patient and operator safety.

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