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

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.