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