Class 2 Device Recall Varian Treatment

• Date Initiated by Firm: July 20, 2011
• Date Posted: August 31, 2011
• Recall Status: Terminated on December 05, 2013
• Recall Number: Z-3105-2011
• Recall Event ID: 59572
• 510(K)Number: K093967
• Product Classification: Linear Accelerator for Radiation Therapy System - Product Code IYE
• Product: Varian Treatment version 6.6.5052.; Varian Medical Systems,; Palo Alto, Ca ; ; Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.
• Code Information: Model H48; Serial numbers: H460150 H462049 H462100 H463014 H463044 H463077 H466021 H466036 H466051 H466067 H460907 H462050 H462123 H463015 H463052 H463078 H466022 H466037 H466052 H466068 H461000 H462051 H462124 H463016 H463053 H463080 H466023 H466038 H466053 H466069 H462003 H462055 H462127 H463017 H463054 H463082 H466024 H466039 H466054 H466075 H462004 H462057 H463000 H463018 H463061 H463083 H466025 H466040 H466055 H466082 H462005 H462061 H463001 H463020 H463062 H463093 H466026 H466041 H466056 H466086 H462006 H462072 H463004 H463024 H463064 H463218 H466027 H466043 H466059 H466091 H462011 H462079 H463006 H463038 H463065 H463377 H466028 H466044 H466061 H466092 H462024 H462080 H463008 H463039 H463068 H465519 H466029 H466045 H466062 H468097 H462030 H462082 H463010 H463040 H463070 H466001 H466030 H466046 H466064 H468098 H462045 H462089 H463012 H463042 H463071 H466011 H466031 H466047 H466065 H462048 H462095 H463013 H463043 H463075 H466017 H466032 H466050 H466066.
• Recalling Firm/ Manufacturer: Varian Medical Systems, Inc. Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: Michael Pignataro; 650-424-6471
• Manufacturer Reason for Recall: Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than intended and would change the shape of the dose distribution for that field.
• FDA Determined Cause: Other
• Action: Varian Medical Systems sent out "Urgent Medical Device Correction/Urgent Field Safety Notice" letters dated July 20, 2011 to all affected customers. The letter identified product, problem and provided recommended user actions when setting up and running the system. It also asked customers to notify appropriate personal provided instructions. For information or questions on this recall please call Varian at (888) VARIAN5 (888- 827-4265).
• Quantity in Commerce: 118
• Distribution: Worldwide Distribution: Nationwide distribution including the states of AZ, CA, FL, GA, IN, MA, MD, MI, MN, MO, NJ, NY, PA, SC, TN, VA and WV; and the countries of Canada, Austria, Belgium, Brazil, Denmark, Finland, France, Germany, India, Ireland, Italy, Lithuania, Poland, Portugal, Romania, South Africa, South Korea, Spain, Sweden, Switzerland and UK.
• 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 = VARIAN MEDICAL SYSTEMS, INC.