# FDA recall Z-0049-2018

> **Edap Technomed Inc.** · Class II · device recall initiated 2017-08-14.

## 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.

## Distribution

US Distribution to states of: NY, FL CA, NC, TX and NJ.

## Key facts

- **Recall number:** Z-0049-2018
- **Recalling firm:** Edap Technomed Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-14
- **Report date:** 2017-11-01
- **Termination date:** 2020-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0049-2018

## Citation

> AI Analytics. FDA recall Z-0049-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0049-2018. Source: US FDA. Licensed CC0.

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