GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
FDA Recall #Z-1405-2015 — Class II — December 19, 2014
Product Description
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
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.
Recalling Firm
GE Healthcare — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6 units US
Distribution
US Distribution to the states of: AZ, FL, GA, MO and WI.
Code Information
BrivoXR285amx - PN 5555000, 5555000-2
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated