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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/fe002e0f-6226-45e7-b6f2-096123b6d94a/
Source feed: China

> China NMPA product recall for Mobile C-arm X-ray system by Philips Healthcare (Suzhou) Co., Ltd. published March 04, 2019. Recall level: Level 2 Recall. Philips Medical (Suzhou) Co., Ltd. initiated a voluntary Class II recall of its Mobile C-arm X-ray S

---

## 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: 2019-03-04
- Product Name: Mobile C-arm X-ray system
- Recall Level: Level 2 Recall
- Recall Reason: The foot switch cable lacks a shielding ferrite core, failing to filter out conducted interference from external sources, which may trigger automatic exposure.
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Medical (Suzhou) Co., Ltd. initiated a voluntary Class II recall of its Mobile C-arm X-ray System, as announced by the National Medical Products Administration (NMPA) on March 4, 2019. The recall addresses a critical manufacturing issue involving the foot switch cable of the BV Vectra system. It was discovered that a lack of a shielding magnetic ring in the cable could lead to premature detection of erroneous signals, potentially resulting in unintended automatic X-ray exposure. This issue affects 27 units distributed within China. While the company assessed the likelihood of occurrence as very low and the potential harm to human health as minimal or nonexistent, users are advised they can continue operating the system according to the instruction manual. To rectify the defect, Philips Medical (Suzhou) Co., Ltd. is implementing a site improvement action (FCO71800080), which involves a site update to correct the problem. This proactive measure aligns with regulatory expectations for ensuring medical device safety and performance. Affected users are encouraged to contact their local Philips site for assistance or questions regarding the necessary corrections.

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