Z-1405-2015Class II

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx

Name: Z-1405-2015 GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Creator: GE Healthcare
Published: 2014-12-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-12-19 / Terminated

FDA source

GE Healthcare began a recall of GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx on 2014-12-19. FDA classified it as Class II and gives the reason as "An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1405-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-04-27
Terminated: 2015-04-29
Recalling firm: GE Healthcare
Product: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Product code: IZL System, X-Ray, Mobile
Reason for recall: An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare planned action: 1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX. 2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance. 3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria. If you have any questions or concerns regarding this notification, please call the Information following phone number: 1-800-437-1171.
Quantity in commerce: 6 units US
Distribution: US Distribution to the states of: AZ, FL, GA, MO and WI.
Product codes and lots: BrivoXR285amx - PN 5555000, 5555000-2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1405-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1405-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27
Z-1406-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27
Z-1407-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27

Product code IZL

K103476Class IIBrivoxr285amx, Optima Xr200amx, Optimaxr220amxGe Medical Systems, LLC / cleared 2011-06-16

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)