Z-1399-2012

GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW...

Name: Z-1399-2012 GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW...
Creator: GE Healthcare, LLC
Published: 2011-12-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-12-23 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima... on 2011-12-23. The reason FDA records is "GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product, related to the light field to x-ray field edge alignment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1399-2012
Status: Terminated
Initiated: 2011-12-23
Posted: 2012-04-24
Terminated: 2014-01-16
Recalling firm: GE Healthcare
Product: GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima XR220 30KW. General Electric, Waukesha, WI Indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
Product code: IZL System, X-Ray, Mobile
Reason for recall: GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product, related to the light field to x-ray field edge alignment.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare will issue an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect and related hazards, along with the safety instructions, affected product, and product correction GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with an approved plan, the details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the external tube port on the source assembly to address the issue. Questions or concerns can be directed to the Call Center at 800-437-1171 or your local GE Healthcare Service Representative.
Quantity in commerce: 130 installed in US
Distribution: USA (nationwide)
Product codes and lots: All associated serial numbers.

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)