Z-2256-2012Class II

Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body

Name: Z-2256-2012 Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body
Creator: GE Healthcare, LLC
Published: 2012-07-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-07-10 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body on 2012-07-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2256-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-10
Posted: 2012-09-13
Terminated: 2013-01-10
Recalling firm: GE Healthcare
Product: Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Product code: IZL System, X-Ray, Mobile
Reason for recall: 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 tag: software
FDA 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 in commerce: 254 total in the US
Distribution: Worldwide Distribution -- USA (nationwide) Distribution
Product codes and lots: Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2256-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2255-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-13
Z-2256-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-13

Product code IZL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)