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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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