Recall Z-0306-2021 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
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.
| Date | Sep 21, 2020 |
| Status | Terminated |
| Reason | There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings. |
| Root cause | Device Design |
| Action | 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: Direc |
| Quantity | 64 devices |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition Ge Medical Systems, LLC, Jul 26, 2019 |