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Open, Classified

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

FDA Recall Z-2041-2020 · Posted None

Recalling FirmImmersivetouch Inc
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2020-04-03
Product Quantity2 units

Reason for Recall

Observed an internal repetitive software glitch in ImmersiveView.

Firm Action

ImmersiveTouch, Inc., notified customers on 04/03/2020 via email titled "Notification of ImmersiveView 2.1 Update". The email informed the customers that the firm will update the software from version 2.1 to 3.0.

Root Cause

Software design

Distribution Pattern

The device was distributed in the state of Illinois only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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