FDA recall Z-0049-2018

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

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

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