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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67504

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

Open FDA event record

Event summary

Timeline bucket
February 06, 2014
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 Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.

Z-1307-2014
Recall number
Z-1307-2014
Initiated
February 06, 2014
Classification
Class II
Status
Terminated
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
151 units Total (88 units domestically & 63 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for dose errors due to software program errors.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for dose errors due to software program errors.

Code information

MODEL #(s): 2.5, 3.0, 3.5 and 4.0; VERSIONS: 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9

Distribution pattern

Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.