FDA Device recall Z-1900-2021
Revolution EVO, Optima CT660, Optima CT680 CT Systems
- FDA Device
- Class II
- ongoing
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of Revolution EVO, Optima CT660, Optima CT680 CT Systems by Ge Healthcare, citing improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1900-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-14 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Reason
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1900-2021%22
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