FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
- Recall number
- Z-2255-2012
- Recalling firm
- GE Healthcare, LLC
- Product
- Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
- Status
- Terminated
- Initiated
- 2012-07-10
- Posted
- 2012-09-13
- Terminated
- 2013-01-10
- Reason
- Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The firm will issue Important Electronic Product Radiation Warning letters that identify the affected product along with a description of the defect and related hazards. Users are instructed to ensure that the acquisition mode is always selected prior to attempting an exposure to confirm the techniques selected. The firm will remedy the issue or bring the device into compliance free of charge. A GE Healthcare Service Representative will update the software on the system to address the issue. Field Modification Instructions (FMI) 10865(2) describes the rework plan the 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. Users are to contact 800-437-1171 in the US, if they have any questions or concerns.
- Quantity
- 254 total in the US
- Distribution
- Worldwide Distribution -- USA (nationwide) Distribution
- Lot, serial or model codes
- Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
- 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