Recall Z-0479-2022— PTW NORTH AMERICA CORPORATION

Name: FDA recall Z-0479-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-27

Class II · Terminated

Class II FDA medical device recall by PTW NORTH AMERICA CORPORATION, initiated 2021-08-27, terminated 2024-02-09. It names one FDA 510(k) clearance: K160405. Product: Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032. 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.

Recalling firm: PTW NORTH AMERICA CORPORATION
Classification: Class II
Status: Terminated
Initiated: 2021-08-27
Terminated: 2024-02-09
Firm location: Boonton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K160405 — OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten·cleared 2017-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.