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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1
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
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