FDAClass IIIMay 27, 2020

ImmersiveView software version 2.1 Product Usage recall: Software Issue

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

Why was ImmersiveView software version 2.1 Product Usage recalled?

Observed an internal repetitive software glitch in ImmersiveView.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

V 2.1

Product
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment…
Recalling firm
Immersivetouch Inc
Quantity
2 units
Distribution
The device was distributed in the state of Illinois only.
Recall date
May 27, 2020
Classification
Class III
Status
Ongoing
Agency
FDA (device)
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