GE Healthcare, LLC Recall 89027
Description: Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
GE Healthcare, LLC Recall 89027 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0242-2022 |
| Event ID | 89027 |
| Event Description | Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition |
| Product Type | Devices |
| Distribution | Worldwide and US Nationwide Distribution |
| Quantity | 105 in total |
| Recall 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. |
| Device Classification | 20211201 |
| Device Code Info | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition |
| Center Classification Date | 20211124 |
| Recall Initiation Date | 20210630 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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