Exact FDA event identifier

Event 87666

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

Open FDA event record

Event summary

Timeline bucket: March 25, 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

RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)

Z-1427-2021

Recall number: Z-1427-2021
Initiated: March 25, 2021
Classification: Class II
Status: Ongoing
Recalling firm: RAYSEARCH LABORATORIES AB
Quantity: 1 system

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

Code information

Software version: 9A, 9B, 10A, 10B

Distribution pattern

US Nationwide in the state of TN.