FDA Device recall Z-1044-2025
Discovery XR656HD. X-Ray imaging system
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of Discovery XR656HD. X-Ray imaging system by Ge Medical Systems, citing the user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure tec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1044-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-28 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
Discovery XR656HD. X-Ray imaging system.
Reason
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
Identifiers
| code_info | GTINs: 00840682142175, 00840682142168 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1044-2025%22
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