FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
- Recall number
- Z-1993-2012
- Recalling firm
- GE Healthcare, LLC
- Product
- GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
- Status
- Terminated
- Initiated
- 2012-04-04
- Posted
- 2012-07-19
- Terminated
- 2013-01-10
- Reason
- GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to the user or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the firmware on the system to address the issue. Your proposed corrective action plan (CAP) (Field Modification Instructions 10865) describes the rework plan that GEHC Engineers will make to the imaging system to return it to compliance with the applicable performance standard. It appears to adequately address the problem and is hereby approved.
- Quantity
- 254 units have been shipped to/installed in the U.S.
- Distribution
- Worldwide Distribution (USA) nationwide
- Lot, serial or model codes
- Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw
- 510(k) numbers
- not on file
- 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