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

Philips Medical Systems (Cleveland), Inc., in conjunction with Philips (China) Investment Co., Ltd., initiated a voluntary Class III recall of its Positron Emission Tomography and X-ray Computed Tomography (PET/CT) Systems, specifically models utilizing Ingenuity TF PET/CT software version 4.0.2. This action was reported to the National Medical Products Administration (NMPA) on January 4, 2019, and published on February 1, 2019. The recall stems from a potential software problem that could necessitate patient rescans. While the risk of patient injury or death is considered extremely low, with no such reports received, the software flaw might lead to additional radiation exposure from repeat CT scans or PET radiopharmaceutical re-injections if PET reconstruction fails. Furthermore, these issues could result in erroneous examination outcomes, including false negatives potentially delaying disease detection, or false positives/indeterminate results that might prompt unnecessary invasive procedures, causing trauma or minor radiation effects. Philips is addressing the issue by updating the system's software. Although the affected product batches were not sold in China, the recall impacts several countries globally. The required actions primarily involve implementing the software correction to mitigate the identified risks and ensure patient safety and accurate diagnostic imaging.