FDAJune 13, 2018device
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
What to do
FDA enforcement status: Terminated
Brands named
beekley
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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