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U.S. Department of Health and Human Services

Class 2 Device Recall PTW

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  Class 2 Device Recall PTW see related information
Date Initiated by Firm August 27, 2021
Create Date January 11, 2022
Recall Status1 Terminated 3 on February 09, 2024
Recall Number Z-0479-2022
Recall Event ID 89314
510(K)Number K160405  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Software BeamAdjust version 2.2, Catalog No: S070009
Software VeriSoft version 8.0, Catalog No: S080032
Code Information S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust
Recalling Firm/
Manufacturer		 PTW NORTH AMERICA CORPORATION
6 Mars Ct Rm Unit 5
Boonton NJ 07005-9309
Manufacturer 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
FDA Determined
Cause 2		 Software design
Action PTW US notified customer Urgent Safety Notice via email and telephone on 8/27/20. Letter states reason for recall, health risk and action to take: PTW will provide free-of-charge software updates. Users who use BeamAdjust 2.2/ VeriSoft 8.0 according to the above described application must update the software to VeriSoft 8.0.1/BeamAdjust 2.2.1 prior to further use of the software. For all other users PTW recommends using BeamAdjust 2.2.1/VeriSoft 8.0.1 too. Until the software updates are available PTW recommends avoiding the air density correction method. As a workaround, if air density correction should still be applied a manually calculated air density correction value can be entered as a kUser keeping kTP untouched (kTP =1.000 !). Please also note, machine QA measurements performed with PTW detector arrays within the PTW software MultiCheck are not affected. TW has fixed the bug in the software and provides all affected users with software updates.
Quantity in Commerce 1 unit
Distribution US Nationwide distribution in the state of CO.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
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