Class II — Edap Technomed Inc.
| Recalling firm | EDAP Technomed Inc. |
|---|---|
| Registered facility | Edap Technomed Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue |
| Quantity | 12 units |
| Distribution | US Distribution to states of: NY, FL CA, NC, TX and NJ. |
| Initiated | 2017-08-14 |
| Classified | 2017-10-26 |
| Terminated | 2020-08-04 |
| Recall number | Z-0049-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Edap Technomed Inc. (Z-0049-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78092/
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