Home GE Healthcare Voluntarily Recalls Revolution Apex CT Systems Due to Potential Central Black Spot Artifacts

GE Healthcare Voluntarily Recalls Revolution Apex CT Systems Due to Potential Central Black Spot Artifacts

Nov 25, 2020 09:21 CST Updated 09:21
GE Healthcare

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Economic Daily - China Economic Net, Beijing, November 25 — On November 23, the National Medical Products Administration (NMPA) website published a report on the voluntary recall of X-ray computed tomography (CT) equipment by GE Healthcare Trade Development (Shanghai) Co., Ltd. (hereinafter referred to as “GE Healthcare”). The recall is classified as Class II.

  

The report indicates that GE Healthcare has recently identified that, in rare instances, certain models and batches of products may potentially exhibit central dark spot artifacts in some Revolution Apex systems. The affected batches were not sold within mainland China.

It is understood that the recalled products are suitable for routine clinical CT examinations, supporting coronary angiography imaging, spectral imaging, and radiotherapy simulation positioning.