Z-1181-2024Class II

Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital...

Name: Z-1181-2024 Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital...
Creator: Ptw-Freiburg
Published: 2024-02-08
License: https://open.fda.gov/license/

PTW-Freiburg / initiated 2024-02-08 / Open, Classified / root cause: software

FDA source

PTW-FREIBURG began a recall of 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... on 2024-02-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1181-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-08
Posted: 2024-02-22
Recalling firm: PTW-Freiburg
Product: 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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: PTW Dosimetry issued Urgent Medical Device Correction letter via email on 2/8/24. Letter states reason for recall, health risk and action to take: PTW recommends not using the Suppress gamma calculation function for ROIs where a high proportion of voxels are to be suppressed in the gamma calculation. Since the malfunction is limited to the GPR calculation of ROIs and does not affect the GPR calculation of the VERIQA Total volume, it is recommended to rely on the comparison based on VERIQA Total. PTW will correct the malfunction in the next software version. The corrected version will be made available to all VERIQA users. The above information should be taken into account by the customer until the installed VERIQA version has been updated. Pass this notice on to everyone at your facility/hospital or at another facility/hospital where the equipment is located who needs to know about it.
Quantity in commerce: 1 US; 65 worldwide
Distribution: GA
Product codes and lots: UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1181-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1181-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-22

Product code IYE

K213370Class IIVeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten / cleared 2022-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)