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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66600

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

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Event summary

Timeline bucket
October 23, 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

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

Z-0281-2014
Recall number
Z-0281-2014
Initiated
October 23, 2013
Classification
Class II
Status
Terminated
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
195 units domestically

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

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

Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

Code information

Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.

Distribution pattern

US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.