Immersivetouch Inc recalls ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating an…

Recall date

April 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2041-2020

FDA classification

Class III

Brand / firm

Immersivetouch Inc

Sold / distributed

The device was distributed in the state of Illinois only.

Why it was recalled

Observed an internal repetitive software glitch in ImmersiveView.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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