Exact FDA event identifier

Event 85475

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: April 03, 2020
Product types: Device
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Immersivetouch Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options

Z-2041-2020

Recall number: Z-2041-2020
Initiated: April 03, 2020
Classification: Class III
Status: Ongoing
Recalling firm: Immersivetouch Inc
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Observed an internal repetitive software glitch in ImmersiveView.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Observed an internal repetitive software glitch in ImmersiveView.

Code information

V 2.1

Distribution pattern

The device was distributed in the state of Illinois only.