CLASS II Device recall · Reported 1 Nov 2017 · FDA Enforcement Report
Ablatherm(R) Integrated Imaging recalled by Edap Technomed
Edap Technomed is recalling Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue, distributed in California, Florida, North Carolina, New Jersey, New York, Texas. The recall was initiated on 14 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0049-2018
- FDA event ID
- 78092
- Recalling firm
- Edap Technomed, Austin, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2017
- FDA classified
- 26 Oct 2017
- Reported
- 1 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 14 Aug 2017 | Recall initiated by company | |
| 26 Oct 2017 | Classified by FDA | +73 days |
| 1 Nov 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Where it was distributed
US Distribution to states of: NY, FL CA, NC, TX and NJ.
Questions about this recall
Is Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue recalled?
Yes. Edap Technomed recalled Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue on 14 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0049-2018.
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267
Where was it sold?
US Distribution to states of: NY, FL CA, NC, TX and NJ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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