FDA recall Z-2041-2020

Immersivetouch Inc · Class III · device

Product

ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options

Reason for recall

Observed an internal repetitive software glitch in ImmersiveView.

Distribution

The device was distributed in the state of Illinois only.

Key facts

Status: Ongoing
Initiation date: 2020-04-03
Report date: 2020-05-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2041-2020