Z-0049-2018 Class II Terminated
FDA device recall Z-0049-2018 was initiated by Edap Technomed Inc. on August 14, 2017 and is designated Class II. 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. unt… The recall status is terminated (terminated August 4, 2020). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2017
- Initiation Date
- August 14, 2017
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
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.
Distribution Pattern
US Distribution to states of: NY, FL CA, NC, TX and NJ.
Code Information
Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267