Edap Technomed Inc. recalls Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensi…

Recall date

August 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0049-2018

FDA classification

Class II

Brand / firm

Edap Technomed Inc.

Sold / distributed

US Distribution to states of: NY, FL CA, NC, TX and NJ.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue