Recall Z-0242-2022 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
| Date | Nov 24, 2021 (initiated Jun 30, 2021) |
| Status | Open, Classified |
| Reason | The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE sent an Important Electronic Product Radiation Warning Notification letter dated October 4, 2021 to customers, The letter identified the affected product, problem and actions to be taken. Customers were informed that GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Health |
| Quantity | 105 in total |
| Distribution | Worldwide and US Nationwide Distribution |
| FDA record | Open on fda.gov |