Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Reported: January 19, 2022 Initiated: August 27, 2021 #Z-0479-2022
Product Description
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Reason for Recall
When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results
Details
- Recalling Firm
- PTW NORTH AMERICA CORPORATION
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of CO.
- Location
- Boonton, NJ
Frequently Asked Questions
What product was recalled? ▼
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032. Recalled by PTW NORTH AMERICA CORPORATION. Units affected: 1 unit.
Why was this product recalled? ▼
When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 19, 2022. Severity: Moderate. Recall number: Z-0479-2022.
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