Z-1993-2012Class II

GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take...

Name: Z-1993-2012 GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take...
Creator: GE Healthcare, LLC
Published: 2012-04-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-04-04 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of 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 (... on 2012-04-04. FDA classified it as Class II and gives the reason as "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...". 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-1993-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-04
Posted: 2012-07-19
Terminated: 2013-01-10
Recalling firm: GE Healthcare
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 )
Product code: IZL System, X-Ray, Mobile
Reason for recall: 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 tag: software
FDA 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 in commerce: 254 units have been shipped to/installed in the U.S.
Distribution: Worldwide Distribution (USA) nationwide
Product codes and lots: Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1993-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1993-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19

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)