Z-0479-2022 Class II Terminated

Recalled by PTW NORTH AMERICA CORPORATION — Boonton, NJ

Recall Details

Product Type
Devices
Report Date
January 19, 2022
Initiation Date
August 27, 2021
Termination Date
February 9, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

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

Distribution Pattern

US Nationwide distribution in the state of CO.

Code Information

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