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Recall Observatory FDA recall evidence

Device product

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

Z-0049-2018

August 14, 2017

Class II

Product summary

Firm
Edap Technomed Inc.
Event
Event 78092
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-0049-2018

Official wording

Reason: 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.

Code information: Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.