Recall Z-0049-2018— Edap Technomed Inc.
Class II · Terminated
Class II FDA medical device recall by Edap Technomed Inc., initiated 2017-08-14, terminated 2020-08-04. It names one FDA 510(k) clearance: K153023. Product: Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue. 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..
- Recalling firm
- Edap Technomed Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-14
- Terminated
- 2020-08-04
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.