China NMPA Product Recall - Positron emission tomography (PET) and X-ray computed tomography (CT) system

On November 3, 2020, the National Medical Products Administration (NMPA) published a notice concerning a voluntary Class III recall by Philips (China) Investment Co., Ltd. This recall impacts their positron emission tomography (PET) and X-ray computed tomography (XCT) systems, specifically the Ingenuity TF PET/CT model (Registration Certificate No.: 20173301760).

The core issue identified relates to the system's Information for Use (IFU), which describes an automatic update function for McAfee virus definition files. However, the current antivirus software providers no longer support the specific McAfee scanner version integrated into these systems. As a result, Philips cannot supply updated virus definition files, yet users continue to receive messages and questions pertaining to this non-functional update feature.

While classified as Class III, signifying that the product is unlikely to cause adverse health consequences, Philips initiated this recall to resolve the software update discrepancy. There have been no reported injuries or fatalities globally linked to this potential issue. The recall underscores the necessity for product documentation to accurately reflect current software support and to avoid presenting users with misleading or non-functional features. Further specifics on affected product models and batches are available in the "Medical Device Recall Event Report Form."