Z-0199-2013Class II

GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body

Name: Z-0199-2013 GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body
Creator: GE Healthcare, LLC
Published: 2012-09-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-09-20 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body on 2012-09-20. FDA classified it as Class II and gives the reason as "It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique...". 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-0199-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Posted: 2012-11-16
Terminated: 2013-12-05
Recalling firm: GE Healthcare
Product: GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare will remedy the defect or bring the product into compliance with each applicable Federal and IEC standard. A Service Representative will update the firmware on the system to address the issue. Field Modification Instructions (FMI) 10870, 10872, and 10873 are describing the rework plan the GEHC Engineers will make to the imaging systems compliant with the applicable performance standard. Further questions please call (262) 513-4122.
Quantity in commerce: 364 total units installed in US
Distribution: Nationwide Distribution
Product codes and lots: part numbers: 5555000-3, 5555000-4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0199-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0197-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0198-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0199-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0200-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16

Product code OXO

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)