CLASS III ONGOING Device recall · Reported 27 May 2020 · FDA Enforcement Report
ImmersiveView software version 2.1 Product Usage: ImmersiveView is recalled
Immersivetouch is recalling ImmersiveView software version 2.1 Product Usage: ImmersiveView is, distributed in Illinois. The recall was initiated on 3 Apr 2020 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2041-2020
- FDA event ID
- 85475
- Recalling firm
- Immersivetouch, Chicago, IL
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 3 Apr 2020
- FDA classified
- 18 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 3 Apr 2020 | Recall initiated by company | |
| 18 May 2020 | Classified by FDA | +45 days |
| 27 May 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Observed an internal repetitive software glitch in ImmersiveView.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Where it was distributed
The device was distributed in the state of Illinois only.
Questions about this recall
Is ImmersiveView software version 2.1 Product Usage: ImmersiveView is recalled?
Yes. Immersivetouch recalled ImmersiveView software version 2.1 Product Usage: ImmersiveView is on 3 Apr 2020. The recall is Class III and its status is Ongoing. Recall number Z-2041-2020.
Why was it recalled?
Observed an internal repetitive software glitch in ImmersiveView.
Which lots are affected?
V 2.1
Where was it sold?
The device was distributed in the state of Illinois only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |