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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88258

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

Open FDA event record

Event summary

Timeline bucket
June 08, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
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 (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0 (10.0.0.1154) 07350002010303; RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365; RayStation 10.1 (10.1.0.613) 07350002010310; RayStation 11.0 (11.0.0.951) 07350002010389;

Z-2138-2021
Recall number
Z-2138-2021
Initiated
June 08, 2021
Classification
Class II
Status
Terminated
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

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

Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

Code information

Product name (build number) UDI-DI RayStation 9.0 (9.0.0.113) 07350002010174 RayStation 9.1 (9.1.0.933) 07350002010266 RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297 RayStation 10.0 (10.0.0.1154) 07350002010303 RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365 RayStation 10.1 (10.1.0.613) 07350002010310 RayStation 11.0 (11.0.0.951) 07350002010389

Distribution pattern

US distribution to TN; and Belgium

Field note

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