GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima

FDA device recall Z-0450-2013 · posted 2012-11-29 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

IZL

Quantity affected

217 total installed in the US

Distribution

Nationwide distribution

Date initiated

2012-08-01

Date posted

2012-11-29

Date terminated

2013-01-10

Location

Waukesha, WI