PTW-Freiburg

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1181-2024Class IISoftware VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digitalFebruary 8, 2024
Z-2577-2023Class IIBeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relativeJune 7, 2023
Z-2439-2015Class IIPTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter May 27, 2015