# China NMPA Product Recall - Mobile C-arm X-ray system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/95391acc-0e2d-4217-943e-2c1e6d6fef0f/
Source feed: China

> China NMPA product recall for Mobile C-arm X-ray system by Philips Healthcare (Suzhou) Co., Ltd. published December 09, 2021. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level Three recall for its Mobile C-Arm 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Healthcare (Suzhou) Co., Ltd. is voluntarily recalling its mobile C-arm X-ray system.
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Publication Date: 2021-12-09
- Product Name: Mobile C-arm X-ray system
- Recall Level: Level 3 Recall
- Recall Reason: The Philips BV Vectra user manual does not specify the maximum surface temperature of the X-ray chamber (X-ray tube assembly housing, X-ray velocity filter, cooling oil) and the system.
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level Three recall for its Mobile C-Arm X-ray Systems, specifically the Philips BV Vectra model, as announced by the National Medical Products Administration (NMPA) on December 9, 2021. The recall stemmed from the company's internal discovery that the product's instruction manual failed to specify the maximum surface temperature for critical components, including the X-ray chamber (X-ray tube assembly housing, X-ray velocity filter, and cooling oil) and the overall system. This omission presented a documentation deficiency regarding potential high surface temperatures during operation, impacting user safety information. The recall affects 264 units distributed within China. In response, Philips Healthcare (Suzhou) Co., Ltd., under the guidance of the provincial Food and Drug Administration, is undertaking corrective measures. These actions involve notifying all affected customers directly and providing a supplementary appendix to the existing BV Vectra system user manual. This appendix will incorporate the previously missing temperature specifications, ensuring users have comprehensive safety instructions for the medical device.

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