GE Healthcare Automatic Mobile X-Ray — Class II medical device recall Z-1405-2015
Terminated recall by GE Healthcare, reported 2015-05-06, distributed in AZ, FL, GA, MO, WI. An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies
| Recall number | Z-1405-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-04-29 |
| Distributed | AZ, FL, GA, MO, WI |
| Quantity | 6 units |
Product
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Reason for recall
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
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-1405-2015. 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.