Class II — GE Healthcare
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx |
| Quantity | 6 units in US |
| Distribution | US Distribution to the states of: AZ, FL, GA, MO and WI. |
| Initiated | 2014-12-19 |
| Classified | 2015-04-27 |
| Terminated | 2015-04-29 |
| Recall number | Z-1406-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare (Z-1406-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70924/
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