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 Vision (tm)

  • 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 Vision (tm) see related information
Date Initiated by Firm October 31, 2003
Date Posted December 03, 2003
Recall Status1 Terminated 3 on December 15, 2003
Recall Number Z-0176-03
Recall Event ID 27629
510(K)Number k992762  
Product Classification Medical Computers And Software - Product Code LNX
Product BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***
Code Information Versions 6.1 and 6.5
Recalling Firm/
Manufacturer		 Varian Brachytherary Virginia
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information Contact Varian Customer Support
800-360-7909
Manufacturer Reason
for Recall		 The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.
FDA Determined
Cause 2		 Other
Action The recalling firm notified consignees by Customer Technical Bulletin on 5/21/03 and additionally by 'URGENT MEDICAL DEVICE CORRECTION LETTER' on 10/31/03. The notifications caution consignees about the need to fully understand scaling functionality and to check scaling for every treatment plan. The notification further explains that the next software release will be modified to include a screen message that appears whenever automatic magnification appears.
Quantity in Commerce 29 sets
Distribution Software was distributed to end users nationwide and internationally.
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 = LNX and Original Applicant = VARIAN ASSOC., INC.
-
-