FDA Medical Device Recalls (openFDA)
Immersivetouch Inc: ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
- Recall number
- Z-2041-2020
- Recalling firm
- Immersivetouch Inc
- Product
- ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
- Status
- Open, Classified
- Initiated
- 2020-04-03
- Posted
- not on file
- Terminated
- not on file
- Reason
- Observed an internal repetitive software glitch in ImmersiveView.
- Root cause
- 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
- 2 units
- Distribution
- The device was distributed in the state of Illinois only.
- Lot, serial or model codes
- V 2.1
- 510(k) numbers
- ["K140860"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3014833795
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28