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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67574

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

Open FDA event record

Event summary

Timeline bucket
March 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Elekta, Inc.

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

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

Z-1322-2014
Recall number
Z-1322-2014
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Recalling firm
Elekta, Inc.
Quantity
498

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.

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

The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.

Code information

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Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CT, FL, GA, KY, LA, MD, MO, NM, NY, NC, OH, OK, PA, TN, TX, and WA and the countries of Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Romania, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.