FDAAugust 9, 2022device
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
What to do
FDA enforcement status: Terminated
Brands named
technomed europetechnomed
UPCs
08718375861530
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDANEUROSIGN Disposable Stimulating Dissector, REF 5888-002024-07-25
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- FDAReny Picot 11 oz Apple Baked Brie UPC 0334215008112022-09-28
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