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

FDA device recall Z-1399-2012 · posted 2012-04-24 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

IZL

Quantity affected

130 installed in US

Distribution

USA (nationwide)

Date initiated

2011-12-23

Date posted

2012-04-24

Date terminated

2014-01-16

Location

Waukesha, WI