Edap Technomed Inc.: Medical Device Recall in 2017 - (Recall #: Z-0049-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 14, 2017

Date Posted: November 1, 2017

Recall Number: Z-0049-2018

Event ID: 78092

Reason for Recall:

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.

Status: Terminated

Product Quantity: 12 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated