GE Healthcare, LLC Recall 88116
Description: Revolution EVO, Optima CT660, Optima CT680 CT Systems.
GE Healthcare, LLC Recall 88116 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1900-2021 |
| Event ID | 88116 |
| Event Description | Revolution EVO, Optima CT660, Optima CT680 CT Systems. |
| Product Type | Devices |
| Distribution | 3,665 (US = 956; OUS = 2,709) |
| Quantity | 3665 |
| Recall Reason | Improperly loaded software options may result in additional X -ray radiation exposure to the patient. |
| Device Classification | 20210707 |
| Device Code Info | Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2 |
| Center Classification Date | 20210625 |
| Recall Initiation Date | 20210614 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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