Exact FDA event identifier

Event 87471

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

Open FDA event record

Event summary

Timeline bucket: March 03, 2021
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: RAYSEARCH LABORATORIES 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

RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.

Z-1281-2021

Recall number: Z-1281-2021
Initiated: March 03, 2021
Classification: Class II
Status: Ongoing
Recalling firm: RAYSEARCH LABORATORIES AB
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

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

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

Code information

S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;

Distribution pattern

US Nationwide distribution in the state of TN.