GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima… recallZ-1406-2015 · GE Healthcare · initiated Dec 19, 2014
Class II Terminated All recalls posted in April 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
GE Healthcare planned action: 1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX. 2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance. 3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria. If you have any questions or concerns regarding this notification, please call the Information following phone number: 1-800-437-1171.
Recall details
- Recall number
- Z-1406-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 19, 2014
- Posted by the FDA
- Apr 27, 2015
- Recalling firm
- GE Healthcare
- Quantity
- 6 units in US
- Product code
- IZL
- FDA submissions
- K142383
- Distribution
- US Distribution to the states of: AZ, FL, GA, MO and WI.
Product description
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
Code information (models, lots, serial numbers)
OptimaXR200amx PN 5555000-3, PN5555000-4
Other devices under the same FDA submission
2 devices cleared under K142383 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Optima XR200amxGE Medical Systems, L.L.C. · System, x-ray, mobile2 recalls1 report
- Optima XR220amxGE Medical Systems, L.L.C. · System, x-ray, mobile2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 70924).
- Z-1407-2015 · TerminatedGE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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