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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65136

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

Open FDA event record

Event summary

Timeline bucket
February 15, 2013
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 Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Z-1419-2013
Recall number
Z-1419-2013
Initiated
February 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
Domestic: 70 units; Foreign: 27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.

Code information

Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.

Distribution pattern

Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.