FDA Medical Device Recalls (openFDA)
PTW FREIBURG: Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
- Recall number
- Z-3174-2026
- Recalling firm
- PTW FREIBURG
- Product
- Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
- Status
- Open, Classified
- Initiated
- 2026-08-04
- Posted
- 2026-09-15
- Terminated
- not on file
- Reason
- When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.
- Root cause
- Software design
- Action
- On August 13, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: If a user is unsure whether a bolus must be used for treatment or not, VERIQA RT MonteCarlo 3D must not be used as the source of information. The user must rely exclusively on the information from the TPS and from the patient record to determine whether a bolus is used for treatment or not. VERIQA RT MonteCarlo 3D must not have any influence on the treatment workflow or on the treatment plan. This error will be fixed in the next VERIQA RT MonteCarlo 3D release. Please forward this notice to everyone in your organization, or in any other organization using VERIQA RT MonteCarlo 3D version 3.1.18, who needs to be aware of it.
- Quantity
- 2
- Distribution
- Worldwide - US Nationwide distribution in the states of GA, NY and the countries of Austria, Belgium, Switzerland, Czechia, Germany, Spain, France, Netherlands, Norway, Poland, Portugal, Romania, T¿rkiye, Chile, United Arab Emirates, Saudi Arabia, Mexico, Hong Kong, Brazil, Tajikistan, Ecuador, Iran, Thailand, Serbia, South Africa, Kazakhstan, Algeria.
- Lot, serial or model codes
- Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18;
- 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