FDAAugust 14, 2017device
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA.
What to do
FDA enforcement status: Terminated
Brands named
edap technomededap
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANEUROSIGN Disposable Stimulating Dissector, REF 5888-002024-07-25
- FDADisposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.2022-08-09
- FDADisposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.2021-12-08
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