GE Healthcare Definium 5000 / 5220493 X-Ray System — Class II medical device recall Z-0703-2013
Terminated recall by GE Healthcare, LLC, reported 2013-03-06, distributed nationwide. When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time
| Recall number | Z-0703-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-09-26 |
| Classified | 2013-02-27 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 312 installed |
| Model numbers | 5000/5220493 |
Product
GE Healthcare Definium 5000 / 5220493 X-Ray System
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0703-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.