Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88084

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

Open FDA event record

Event summary

Timeline bucket
August 06, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
C-RAD POSITIONING AB

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

PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

Z-2075-2021
Recall number
Z-2075-2021
Initiated
August 06, 2020
Classification
Class II
Status
Terminated
Recalling firm
C-RAD POSITIONING AB
Quantity
7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

Code information

Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0

Distribution pattern

US Nationwide distribution in the states of IL, KY, MO and WA.