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U.S. Department of Health and Human Services

Class 2 Device Recall Ablatherm Integrated Imaging device

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 Class 2 Device Recall Ablatherm Integrated Imaging devicesee related information
Date Initiated by FirmAugust 14, 2017
Create DateOctober 26, 2017
Recall Status1 Terminated 3 on August 04, 2020
Recall NumberZ-0049-2018
Recall Event ID 78092
510(K)NumberK153023 
Product Classification High intensity ultrasound system for prostate tissue ablation - Product Code PLP
ProductAblatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Code Information Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267
Recalling Firm/
Manufacturer		 Edap Technomed Inc.
5321 Industrial Oaks Blvd Ste 110
Austin TX 78735-8823
For Additional Information ContactHugo Embert
512-832-7956
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionThe firm, EDAP TMS, company contacted all affected customers by phone during the week of August 14, 2017 and followed up with an " URGENT FIELD SAFETY NOTICE" letter dated 8/22/2017 delivered by email on 08/29/2016. The letter described the product, problem and actions to be taken. The customers were instructed as follows: do not use the "medium" or "low" energy treatment power settings in the meantime.The devices will be serviced at the consignee to remove Protocols "02-medium" and "03-low". If you have any questions regarding this notification, or experience any issues with your device, please contact EDAP TMS Customer Care Center at (512) 852-9685 or via email at service@edap-usa.com at any time, 24 hours a day, 7 days a week.
Quantity in Commerce12 units
DistributionUS Distribution to states of: NY, FL CA, NC, TX and NJ.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PLP
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