Z-2041-2020Class III

ImmersiveView software version 2.1

Name: Z-2041-2020 ImmersiveView software version 2.1
Creator: Immersivetouch Inc
Published: 2020-04-03
License: https://open.fda.gov/license/

ImmersiveTouch, Inc. / initiated 2020-04-03 / Open, Classified / root cause: software

FDA source

Immersivetouch Inc began a recall of ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options on 2020-04-03. FDA classified it as Class III and gives the reason as "Observed an internal repetitive software glitch in ImmersiveView". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2041-2020
Classification: Class III
Status: Open, Classified
Initiated: 2020-04-03
Posted: 2020-05-18
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
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Observed an internal repetitive software glitch in ImmersiveView.
Root cause tag: software
FDA 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 in commerce: 2 units
Distribution: The device was distributed in the state of Illinois only.
Product codes and lots: V 2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2041-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2041-2020	Class III	Ongoing	Voluntary: Firm initiated	2020-05-27	2020-05-18

Product code LLZ

K140860Class IIImmersiveTouch3 and MicrovisTouchImmersivetouch / cleared 2014-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)