The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0049-2018·Announced 2017-11-01

FDA Requests Removal of Ablatherm Ultrasound System Software Settings

FDA requested the removal of specific energy treatment settings from 12 Ablatherm ultrasound systems in the U.S. pending clinical data evaluation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has requested that the optional energy treatment settings labeled "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imaging devices currently in the United States. This action is being taken until supporting clinical data can be submitted and evaluated by the FDA.

The recall involves 12 units of the Ablatherm Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation, manufactured by Edap Technomed Inc. The affected devices are distributed in the states of New York, Florida, California, North Carolina, Texas, and New Jersey. The specific serial numbers for the affected units are AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, and AB267.

Healthcare providers and facilities using these devices should contact Edap Technomed Inc. to ensure the specified software protocols are removed from the systems. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Manufacturer
Edap Technomed Inc.
Category
Medical Device — Ultrasound System
Hazard
Affected units
12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Serial Numbers: AB127r
  • AB206r
  • AB220r
  • AB254r
  • AB200r
  • AB214r
  • AB223r
  • AB266
  • AB204r
  • AB217r
  • AB224r
  • AB267

Distribution

Distributed in 6 states:

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