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Recall Observatory FDA recall evidence

Device product

Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

Z-0479-2022

August 27, 2021

Class II

Product summary

Firm
PTW NORTH AMERICA CORPORATION
Event
Event 89314
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0479-2022

Official wording

Reason: 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

Code information: S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust

Distribution pattern: US Nationwide distribution in the state of CO.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error