Reported May 27, 2020 · Ongoing

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

Immersivetouch Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Immersivetouch Inc · 910 W Van Buren St Ste 715 · Chicago, IL · 60607-3573

Is this the product you have?

  • ImmersiveView software version 2.1
  • Product UsageImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Lot codes and dates
  • V 2.1
Amount recalled
2 units

Where it was sold

Why it was recalled

Observed an internal repetitive software glitch in ImmersiveView.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:29 PM UTC

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