FDAMay 11, 2017device

Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and is...

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

The hazard

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

What to do

FDA enforcement status: Terminated

Brands named

ge medical systems

UPCs

00840682115971008406821158720084068210381700840682105699840682105378

Recall history

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

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Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and is... — Recall Details · AllClear