FDA Device recall Z-1405-2015
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx by Ge Healthcare, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1405-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-19 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | AZ, FL, GA, MO, WI |
Product
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
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.
Identifiers
| code_info | BrivoXR285amx - PN 5555000, 5555000-2 |
|---|
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-1405-2015%22
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