Medical device recalls Moderate risk

GE Healthcare recalls GE Discovery MR950 MRI system

Recall date
October 24, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1395-2015
FDA classification
Class II
Brand / firm
GE Healthcare
Sold / distributed
US Distribution to the state of CA., and Internationally to Italy and Japan.

Why it was recalled

The alignment lasers are missing the labels required by radiation safety regulations.

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 Discovery MR950 MRI system

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