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FDASeptember 14, 2020device

MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

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

The hazard

The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.

What to do

FDA enforcement status: Terminated

Brands named

invivo

UPCs

45221504020245221504036245353005458145353007107145353007127145353007128153530277861453530277871453530277891453530294611453530294612453530294613

Recall history

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

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