Recall – Pre-operative surgical treatment software error

Company: Immersivetouch Inc
Date of Enforcement Report: 6/10/2020
Class II

PRODUCT

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

Recall Number: Z-2041-2020

REASON

Observed an internal repetitive software glitch in ImmersiveView.

RECALLING FIRM/MANUFACTURER

Immersivetouch Inc on 4/3/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

US Nationwide

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