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 (CT) equipment, as reported to the National Medical Products Administration (NMPA) on December 8, 2015, with public notification on December 10, 2015. This recall addresses two significant software-related deficiencies impacting image quality and diagnostic utility. The first issue involves "tracking image artifacts" encountered during CT angiography (CTA) examinations. These linear artifacts can lead to inaccurate scan triggering, potentially failing to capture crucial contrast agent peaks, resulting in suboptimal CT images unsuitable for clinical diagnosis. The second deficiency concerns "ring/dot image artifacts" appearing in reconstructed images under specific conditions: after a complete system power-off and restart, if a head scan is performed without prior air correction and without utilizing a fast IQ scan. The recall encompasses equipment registered under CFDA Medical Device Approval Numbers 20133301488, 20143300672, and 20133300671, affecting 98 units sold in China. To date, no injury incidents related to these issues have been reported. As a required action under the NMPA regulatory framework, Philips Healthcare (Suzhou) has already informed affected users and implemented a Field Corrective Action (FCO). This involves field engineers contacting customers to schedule and perform necessary software upgrades to resolve the identified imaging defects.