Medical device recalls Moderate risk

GE Inspection Technologies, LP recalls GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for…

Recall date
March 2, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2236-2016
FDA classification
Class II
Brand / firm
GE Inspection Technologies, LP
Sold / distributed
US Distribution to the states of : FL, TN, and TX.

Why it was recalled

Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.

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, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.

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