China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall for its Ingenuity Core 128 X-ray Computed Tomography Equipment. This action, reported on September 27, 2017, and published by the National Medical Products Administration (NMPA) on October 9, 2017, addresses a critical software issue. The main problem stems from software version 4.1.6, which prevents image generation during contrast agent tracking scans. This failure leads to an inability to obtain raw data for offline reconstruction, potentially requiring repeat CT scans for patients. The recall falls under the regulatory oversight of the NMPA, indicating adherence to Chinese medical device regulations, with the product originally approved under CFDA (Approval) No. 20133301488. Philips Healthcare (Suzhou) Co., Ltd. responded by issuing on-site safety notification letters to affected users and implementing specific on-site improvement measures (FCO72800675) to correct the software defect. A total of 47 affected units were distributed and subsequently addressed in China to ensure the equipment's reliability for diagnostic purposes.