FDA Medical Device Recalls (openFDA)
GE Healthcare: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
- Recall number
- Z-1406-2015
- Recalling firm
- GE Healthcare
- Product
- GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
- Status
- Terminated
- Initiated
- 2014-12-19
- Posted
- 2015-04-27
- Terminated
- 2015-04-29
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 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.
- Quantity
- 6 units in US
- Distribution
- US Distribution to the states of: AZ, FL, GA, MO and WI.
- Lot, serial or model codes
- OptimaXR200amx PN 5555000-3, PN5555000-4
- 510(k) numbers
- ["K142383"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28