CLASS II ONGOING Device recall · Reported 28 Feb 2024 · FDA Enforcement Report

Software Veriqa (S070031), version 2.0 and 2.1- Software package recalled

Ptw-freiburg is recalling Software Veriqa (S070031), version 2.0 and 2.1- Software package for, distributed in Georgia. The recall was initiated on 8 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1

Quantity recalled1 US; 65 worldwide

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1181-2024
FDA event ID: 93988
Recalling firm: Ptw-freiburg, Freiburg Im Breisgau, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 8 Feb 2024
FDA classified: 22 Feb 2024
Reported: 28 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

8 Feb 2024	Recall initiated by company
22 Feb 2024	Classified by FDA	+14 days
28 Feb 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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23 Sep 2026Device	CLASS II	Veriqa RT MonteCarlo 3D v3 recalled by PTW Freiburg	PTW Freiburg	Device Malfunction	Nationwide
20 Sep 2023Device	CLASS II	BeamAdjust software Version 2.3.3 Ref: S080032 The following devices recalled	Ptw-freiburg	Device Malfunction	Nationwide
2 Sep 2015Device	CLASS II	PTW Unidos webline recalled by PTW-Freiburg	Ptw-Freiburg	Other	10 states

Other Medical Software recalls

All 908

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Volara System Volara, HC, NA recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Enterprise Archive V8 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Veriqa RT MonteCarlo 3D v3 recalled by PTW Freiburg	PTW Freiburg	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide