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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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