Z-0049-2018Class II

Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal...

Name: Z-0049-2018 Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal...
Creator: Edap Technomed Inc.
Published: 2017-08-14
License: https://open.fda.gov/license/

Edap Technomed Inc. / initiated 2017-08-14 / Terminated / root cause: software

FDA source

Edap Technomed Inc. began a recall of Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of... on 2017-08-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0049-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-14
Posted: 2017-10-26
Terminated: 2020-08-04
Recalling firm: Edap Technomed Inc.
Product: Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Product code: PLP High Intensity Ultrasound System For Prostate Tissue Ablation
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.
Root cause tag: software
FDA root cause: Other
Action: The 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 [email protected] at any time, 24 hours a day, 7 days a week.
Quantity in commerce: 12 units
Distribution: US Distribution to states of: NY, FL CA, NC, TX and NJ.
Product codes and lots: Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0049-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0049-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-01	2017-10-26

Product code PLP

K153023Class IIAblatherm Integrated ImagingEdap Technomed, Inc. / cleared 2015-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)