FDA Medical Device Recalls (openFDA)
PTW-FREIBURG: 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.
- Recall number
- Z-1181-2024
- 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.
- Status
- Open, Classified
- Initiated
- 2024-02-08
- Posted
- 2024-02-22
- Terminated
- not on file
- Reason
- 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
- 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
- 1 US; 65 worldwide
- Distribution
- GA
- Lot, serial or model codes
- UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1
- 510(k) numbers
- ["K213370"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3007360740
- Firm city
- Freiburg Im Breisgau
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28