FDAJuly 23, 2015device

Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems

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

The hazard

Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.

What to do

FDA enforcement status: Terminated

Brands named

philips medical systems clevelandphilipsphilips medical

Recall history

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

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