# China NMPA Product Recall - Digital X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/9b122773-f591-4568-add4-2a0116a9b3c9/
Source feed: China

> China NMPA product recall for Digital X-ray machine by Philips Healthcare (Suzhou) Co., Ltd. published August 02, 2022. Recall level: Level 2 Recall. Philips Medical (Suzhou) Co., Ltd., operating under the regulatory framework of China's National Med

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Healthcare (Suzhou) Co., Ltd. voluntarily recalls digital radiography X-ray machines
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Publication Date: 2022-08-02
- Product Name: Digital X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: Philips discovered that after the equipment was restarted, when the operator switched the equipment from the default Height 2 (TH2) to the chest X-ray stand Wallstand VS2, the image display orientation was incorrect. This was because the Wallstand VS2 control system rotated the selected ionization chamber detection field by 90°, moving the anatomical position to the other side of the anatomical position.
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Medical (Suzhou) Co., Ltd., operating under the regulatory framework of China's National Medical Products Administration (NMPA), initiated a voluntary, level two global recall for 90 units of its Digital X-ray Machines. This recall was officially reported on August 2, 2022, addressing a significant technical malfunction. The core issue arises when, after restarting the equipment and switching from the default 'Height 2' setting to the 'Wallstand VS2' chest X-ray stand, the displayed image orientation is incorrect. This defect is attributed to the Wallstand VS2 control system, which erroneously rotates the selected ionization chamber detection field by 90 degrees. The recall impacts various DigitalDiagnost models, including the C50, 65 HAT, and 2000 series, with specific serial numbers identified. Philips Healthcare (Suzhou) Co., Ltd. has not received any adverse event reports related to this particular issue. As a required action, Philips will notify all affected users (FC071200225) and provide essential firmware updates for the impacted devices. Company engineers are tasked with contacting users directly to arrange and conduct the necessary on-site corrective actions, ensuring the safe and proper functionality of the equipment.

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