FDAJune 4, 2018device

Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.

What to do

FDA enforcement status: Terminated

Brands named

fx solutions

UPCs

03701037300510

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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