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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/8a1a0d80-07e3-475b-b955-adc988cf242b
Source feed: China

> China NMPA product recall for Mobile C-arm X-ray system; Mobile C-arm X-ray equipment by Philips (China) Investment Co., Ltd. published December 07, 2021. Recall level: Level 3 Recall. Philips (China) Investment Co., Ltd. announced a voluntary Level III recall of its Mobile C-arm X-ra

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling its Mobile C-arm X-ray Equipment.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-12-07
- Product Name: Mobile C-arm X-ray system; Mobile C-arm X-ray equipment
- Recall Level: Level 3 Recall
- Recall Reason: The instruction manuals for the affected products do not specify the maximum surface temperatures of the X-ray chamber (X-ray tube assembly housing, X-ray beam filter, and cooling oil) and the system image intensifier/detector.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. announced a voluntary Level III recall of its Mobile C-arm X-ray Systems and Mobile C-arm X-ray Equipment. This action was publicly reported on December 7, 2021, under the regulatory oversight of the National Medical Products Administration (NMPA).

The primary reason for the recall stems from an oversight in the instruction manuals provided with the affected medical devices. Philips discovered that these manuals did not adequately specify crucial safety parameters: the maximum surface temperature of the X-ray chamber components, which include the X-ray tube assembly housing, X-ray beam filter, and cooling oil. Additionally, the manuals failed to provide the maximum surface temperature for the system's image intensifier/detector.

This Level III classification indicates that while there is an issue, the use of or exposure to the product is not likely to cause adverse health consequences. Philips (China) Investment Co., Ltd. is taking corrective action to address these informational deficiencies. Further detailed information regarding specific affected product models, specifications, and batches is available in the associated Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b