The Recall Desk
LowFDA (Devices)·Z-2041-2020·Announced 2020-05-27

ImmersiveView software version 2.1 recalled for internal repetitive glitch

Immersivetouch Inc is recalling two units of ImmersiveView software version 2.1 due to an observed internal repetitive software glitch.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Immersivetouch Inc is recalling two units of ImmersiveView software version 2.1. The software is intended as pre-operative software for simulating and evaluating surgical treatment options.

The recall was initiated because an internal repetitive software glitch was observed in the device. The agency has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

The device was distributed in the state of Illinois only. Users should contact the recalling firm for further instructions on how to proceed with the recall.

The recalled product

Product
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Manufacturer
Immersivetouch Inc
Category
Medical Device — Software
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • V 2.1

Distribution

Distributed in 1 state:

Related recalls

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