Radiotherapy Planning Software BeamAdjust and VeriSoft Recalled for Measurement Errors
PTW North America is recalling BeamAdjust 2.2 and VeriSoft 8.0 software due to measurement errors that can report incorrect radiation doses in patient treatment plans.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall affecting a risk-of-harm product (radiotherapy dose planning), where measurement errors could compromise treatment accuracy. However, no illnesses or injuries have been reported, placing it at the High severity level per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
PTW North America Corporation is recalling BeamAdjust version 2.2 (Catalog No. S070009) and VeriSoft version 8.0 (Catalog No. S080032). These software tools are used with PTW detector arrays to measure and verify radiation doses in radiotherapy treatment planning.
Under specific conditions, a measurement error can occur when these software versions are used with PTW detector arrays. The error can result in measured absolute dose values that are either too low or too high. These inaccurate measurements directly affect the accuracy of patient plan verification results.
Healthcare facilities and radiotherapy departments using affected software versions should review their installations and contact PTW North America Corporation regarding this recall. The FDA recommends that affected users verify the accuracy of dose calculations and implement appropriate corrective measures to ensure measurement reliability.
The recalled product
- Product
- Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
- Manufacturer
- PTW NORTH AMERICA CORPORATION
- Hazard
- measurement-error
- dose-miscalculation
- treatment-planning-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft
- EPTWS0700090 BeamAdjust
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateProvena Midline Catheters recalled due to deficient manufacturing practices
FDA (Devices) · 2026-07-08
- ModeratePowerPICC Provena Catheters recalled for deficient manufacturing practices
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Recalled Due to Lidocaine Quality Issues
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08