Z-0450-2013Class II

GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo...

Name: Z-0450-2013 GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo...
Creator: GE Healthcare, LLC
Published: 2012-08-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-08-01 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended... on 2012-08-01. 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 XR22Oamx and Optima XR200amx with Digital Upgrade". 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-0450-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-01
Posted: 2012-11-29
Terminated: 2013-01-10
Recalling firm: GE Healthcare
Product: GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
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 XR22Oamx and Optima XR200amx with Digital Upgrade.
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 through a GE Healthcare field engineer site visit. Field Modification Instructions (FMI) 10868 describes the rework plan the GEHC Engineers will make to the imaging system compliant with the applicable performance standard. This CAP appears to adequately address the problem and is hereby approved. Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.
Quantity in commerce: 217 total installed in the US
Distribution: Nationwide distribution
Product codes and lots: Model No - 5421698

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0450-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0448-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-29
Z-0449-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-29
Z-0450-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-29

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)