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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93988

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

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Event summary

Timeline bucket
February 08, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PTW-FREIBURG

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

Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

Z-1181-2024
Recall number
Z-1181-2024
Initiated
February 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
PTW-FREIBURG
Quantity
1 US; 65 worldwide

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.

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

Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.

Code information

UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1

Distribution pattern

GA