China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall of its X-ray computed tomography equipment (model Ingenuity Core 128), as reported on August 22, 2017, and published by the National Medical Products Administration (NMPA) on August 24, 2017. This action addresses a significant system error affecting 47 units within China. The primary issue occurs during non-gated contrast agent bolus tracking clinical scans. When the system reaches a specific threshold, it generates an error message, causing the scan sequence to cancel and leading to the loss of contrast agent. This malfunction potentially necessitates a rescan and impacts systems running software versions 4.1.6.XX030 or 4.1.6.XX032. Under the NMPA's regulatory framework, Philips Healthcare (Suzhou) Co., Ltd. responded by issuing a field safety notification and a specific field improvement measure (FCO72800675) to correct the software defect. Additionally, all customers with the affected equipment received direct notification letters to ensure timely resolution and maintain diagnostic reliability.