Edap Technomed Ablatherm Ultrasound System Recall: Remove Medium/Low Energy Settings
Edap Technomed recalls Ablather: Integrated Imaging ultrasound devices in the US for prostate ablation. FDA requires removal of medium and low energy settings until clinical data is submitted.
Recall notice
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.
Contact the company
What happened, in plain English
Edap Technomed is recalling specific ultrasound devices for prostate tissue ablation due to FDA requests to remove optional energy settings. This recall is to prevent potential risks until clinical data is submitted for review. Read more at govinfonow.com/recall/73143-edap-technomed-ablatherm-ultrasound-system-recall-remove-medium-low-energy.
Source Summary by GovInfoNow · govinfonow.com/recall/73143-edap-technomed-ablatherm-ultrasound-system-recall-remove-medium-low-energy · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0049-2018
Cite this page
“Edap Technomed Ablatherm Ultrasound System Recall: Remove Medium/Low Energy Settings.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73143-edap-technomed-ablatherm-ultrasound-system-recall-remove-medium-low-energy. Based on FDA recall #Z-0049-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0049-2018%22&limit=1).
Why it’s dangerous
The FDA requires removing medium and low energy settings from the devices until clinical data is submitted for review. This suggests a potential safety issue that could affect treatment outcomes if not addressed.
Who’s affected
Patients and medical professionals using the recalled Ablatherm devices for prostate ablation procedures. Those with the specific serial numbers listed are most at risk.
How to tell if you have this one
Check for the serial numbers AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267 on the device. The device is used for transrectal high-intensity focused ultrasound (HIFU) prostate tissue ablation.
- Brand
Edap Technomed- Category
Medical device
What to do — step by step
Check Device Serial Number
Identify the serial number on the device to confirm if it is one of the recalled numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267.
Where it went and when
Where it was distributed
Distributed in 6 states.
FDA distribution: “US Distribution to states of: NY, FL CA, NC, TX and NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, New Jersey, New York, North Carolina, Texas.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0049-2018 (August 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0049-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.