Ablatherm — Class II medical device recall Z-0049-2018
Terminated recall by Edap Technomed Inc., reported 2017-11-01, distributed in CA, FL, NC, NJ, NY, TX. The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Med
| Recall number | Z-0049-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edap Technomed Inc., Austin, TX, United States |
| Recall initiated | 2017-08-14 |
| Classified | 2017-10-26 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2020-08-04 |
| Distributed | CA, FL, NC, NJ, NY, TX |
| Quantity | 12 units |
| Reason classes | software |
| Serial numbers | AB127R, AB200R, AB204R, AB206R, AB214R, AB217R, AB220R, AB223R, AB224R, AB254R, AB266, AB267 |
Product
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0049-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.