Z-2041-2020 Class III Ongoing

Recalled by Immersivetouch Inc — Chicago, IL

Recall Details

Product Type
Devices
Report Date
May 27, 2020
Initiation Date
April 3, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

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 Pattern

The device was distributed in the state of Illinois only.

Code Information

V 2.1