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Edap Technomed Recalls

1 recall on record · November 1, 2017 to November 1, 2017 · Medical Devices

November 1, 2017Medical DevicesFDA
Edap Technomed Inc. recalls Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high inte
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.
Edap Technomed Recalls | RecallWatchUSA