Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BeamAdjust

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall BeamAdjust see related information
Date Initiated by Firm June 07, 2023
Date Posted September 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-2577-2023
Recall Event ID 92879
510(K)Number K160405  
Product Classification Accelerator, linear, medical - Product Code IYE
Product BeamAdjust software Version 2.3.3
Ref: S080032
The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ):
" OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560)
" OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570)
" OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580)
" OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)
Code Information UDI-DI: EPTWS0800320 BeamAdjust All software Versions
Recalling Firm/
Manufacturer		 PTW-FREIBURG
Lorracher Str. 7
Freiburg Im Breisgau Germany
Manufacturer Reason
for Recall		 Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result will be incorrect by using such a calibration file.
FDA Determined
Cause 2		 Under Investigation by firm
Action PTW North America notified US End users via email and attached Urgent Medical Device Correction letter from PTW Freiberg on 8/23/23. Letter states reason for recall, health risk and action to take: PTW does not recommend performing a relative calibration of the OD 1000 and OD 1600 using Tiff files and DICOM data sets and recommends using alternative reference matrices. A correct result can also be generated if the reference matrix for relative calibration is rotated 90¿ counterclockwise in VeriSoft and saved before loading into ArrayCal. The information mentioned above should be observed by the customer. No further action is required. Pass this notice on to everyone at your facility/hospital or at another facility/hospital where the equipment is located who needs to know about it.
Quantity in Commerce 42 US
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
-
-