Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0479-2022 — Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

U.S. FDA — Device Enforcement · United States · 2021-08-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0479-2022
Date of alert
2021-08-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
PTW NORTH AMERICA CORPORATION
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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