Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

The recall strategy outlined below addresses the depth of the recall and recall notification (customer letter) effectiveness check. This issue will be resolved by sending an Urgent Medical Device Correction letter (attached) to customers with potentially affected systems. This letter will inform the customer of the issue and provide safety instructions for continued use. GE Healthcare will inspect potentially affected systems and correct, if needed. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the inspection and correction, if needed, of potentially affected systems. Records will be retained per our processes and procedures.