FDA Device recall Z-0703-2013
GE Healthcare Definium 5000 / 5220493 X-Ray System
- FDA Device
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of GE Healthcare Definium 5000 / 5220493 X-Ray System by Ge Healthcare, citing when quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display differ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0703-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-26 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Definium 5000 / 5220493 X-Ray System
Reason
When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.
Identifiers
| code_info | Definium Model 5000/5220493 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0703-2013%22
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