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

FDA device recall Z-1993-2012 · posted 2012-07-19 · 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 XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.

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 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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

IZL

Quantity affected

254 units have been shipped to/installed in the U.S.

Distribution

Worldwide Distribution (USA) nationwide

Date initiated

2012-04-04

Date posted

2012-07-19

Date terminated

2013-01-10

Location

Waukesha, WI