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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66808

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

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Event summary

Timeline bucket
August 20, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Iba Dosimetry Gmbh

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

iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

Z-0456-2014
Recall number
Z-0456-2014
Initiated
August 20, 2013
Classification
Class II
Status
Terminated
Recalling firm
Iba Dosimetry Gmbh
Quantity
33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.

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 development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.

Code information

SW Version 3.0. Catalong Number CS10-100

Distribution pattern

Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.