Medical device recalls Moderate risk

Ion Beam Applications S.A. recalls Proteus 235, graphite block 8

Recall date
October 17, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0930-2018
FDA classification
Class II
Brand / firm
Ion Beam Applications S.A.
Sold / distributed
WA

Why it was recalled

IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader

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

What was recalled

Proteus 235, graphite block 8

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