GE Healthcare recalls GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx

Recall date

December 19, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1406-2015

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

US Distribution to the states of: AZ, FL, GA, MO and WI.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx