GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
FDA Recall #Z-1406-2015 — Class II — December 19, 2014
Product Description
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
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 in US
Distribution
US Distribution to the states of: AZ, FL, GA, MO and WI.
Code Information
OptimaXR200amx PN 5555000-3, PN5555000-4
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated