GE Healthcare, LLC Recall 89762
Description: Revolution Apex, Revolution CT with Apex Edition
GE Healthcare, LLC Recall 89762 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0815-2022 |
| Event ID | 89762 |
| Event Description | Revolution Apex, Revolution CT with Apex Edition |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution. |
| Quantity | 273 (51 US, 222 OUS) in total |
| Recall Reason | The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high. |
| Device Classification | 20220413 |
| Device Code Info | Revolution Apex, Revolution CT with Apex Edition |
| Center Classification Date | 20220405 |
| Recall Initiation Date | 20210630 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
| Similar To |