Medical device recalls Moderate risk

GE Inspection Technologies, LP recalls GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.

Recall date
January 13, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1225-2015
FDA classification
Class II
Brand / firm
GE Inspection Technologies, LP
Sold / distributed
US Distribution to the states of OH and PA.

Why it was recalled

It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding.

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 Inspection Technologies x|argos 160D system. Cabinet x-ray system.

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