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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 ImmersiveView see related information
Date Initiated by Firm April 03, 2020
Create Date May 18, 2020
Recall Status1 Open3, Classified
Recall Number Z-2041-2020
Recall Event ID 85475
510(K)Number K140860  
Product Classification System, image processing, radiological - Product Code LLZ
Product ImmersiveView 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
Action ImmersiveTouch, 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 Commerce 2 units
Distribution The device was distributed in the state of Illinois only.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = IMMERSIVE TOUCH
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