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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89314

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

Open FDA event record

Event summary

Timeline bucket
August 27, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
PTW NORTH AMERICA CORPORATION

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 BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

Z-0479-2022
Recall number
Z-0479-2022
Initiated
August 27, 2021
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error

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

When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results

Code information

S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust

Distribution pattern

US Nationwide distribution in the state of CO.