FDA-Device2017-11-01Class II
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Edap Technomed Inc.
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.
Sold states
US Distribution to states of: NY, FL CA, NC, TX and NJ.
Affected count
12 units
Manufactured in
5321 Industrial Oaks Blvd Ste 110, N/A, Austin, TX, United States
Products
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0049-2018Don't want to check this manually?
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