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U.S. Department of Health and Human Services

Class 3 Device Recall ImmersiveView

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 Class 3 Device Recall ImmersiveViewsee related information
Date Initiated by FirmApril 03, 2020
Create DateMay 18, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2041-2020
Recall Event ID 85475
510(K)NumberK140860 
Product Classification System, image processing, radiological - Product Code LLZ
ProductImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Code Information V 2.1
Recalling Firm/
Manufacturer
Immersivetouch Inc
910 W Van Buren St Ste 715
Chicago IL 60607-3573
For Additional Information Contact
773-840-5227
Manufacturer Reason
for Recall
Observed an internal repetitive software glitch in ImmersiveView.
FDA Determined
Cause 2
Software design
ActionImmersiveTouch, Inc., notified customers on 04/03/2020 via email titled "Notification of ImmersiveView 2.1 Update". The email informed the customers that the firm will update the software from version 2.1 to 3.0.
Quantity in Commerce2 units
DistributionThe device was distributed in the state of Illinois only.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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