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U.S. Department of Health and Human Services

Class 2 Device Recall Varian Medical Systems VitalBeam Radiosurgical System

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  Class 2 Device Recall Varian Medical Systems VitalBeam Radiosurgical System see related information
Date Initiated by Firm August 20, 2018
Create Date October 01, 2018
Recall Status1 Terminated 3 on August 28, 2020
Recall Number Z-0005-2019
Recall Event ID 81010
510(K)Number K150706  
Product Classification Accelerator, linear, medical - Product Code IYE
Product VitalBeam Radiotherapy Delivery System Version 2.5

Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Code Information VitalBeam Version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H192482 VITAL BEAM - 321274492 H192521 VITAL BEAM H192743 VITAL BEAM H192816 VITAL BEAM  Varian Product Code family H19, which includes TrueBeam, TrueBeam STx, VitalBeam and EDGE.
Recalling Firm/
Manufacturer		 Varian Medical Systems
3100 Hansen Way
Palo Alto CA 94304-1030
Manufacturer Reason
for Recall		 Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
FDA Determined
Cause 2		 Software design
Action On 08/20/2018 the firm sent an URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE to customer via courier service (US and Canada via FedEx on 8/23/2018, and Rest of World via third party courier on 8/24/2018) informing them the firm had received reports of an anomaly that can result in a treatment without intended gating, and that this issue occurs when a patient planned with gating is treated on more than one system. Customers were advised, for treatment plans with intended gating, the firm recommends users monitor and pay attention to the system status message. When a patient with a gated treatment plan is moved to a second system, users must verify that intending gating was not overridden. If gating is overridden, users should reselect it from the Tools menu. The customer were informed that they will be contacted by a Customer Service Representative to schedule upgrade to the correction when available and if they have any questions regarding selecting gating from the Tools menu to contact customer support. Help Desk Contact Information: Phone: +1.888.827.4265 Email: support @varian.com In addition, the URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE, informs the customers to: 1) Please retain a copy of this document along with your most current product labeling. 2) Advise the appropriate personnel working in your radiotherapy department of the content of this letter. 3) For future reference, this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. and In order to satisfy regulatory requirements, we request that you complete the attached Recall Return Response form provided. Kindly return the completed form to returnresponse@varian.com.
Quantity in Commerce 4
Distribution Worldwide Distribution - US nationwide in the states of AL, AR, AZ, CA, CO, FL, Guan, IL IN, KS, KY, LA, MA, MD, MI, MO, NH, NJ, NY, OH, OK, PA, Puerto Rico, TN, TX, VA, WI and the countries of : Algeria, Australia, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, India, Ireland, Israel, Italy, Japan, Kazakhstan, Lebanon, Morocco, Nepal, The Netherlands, New Zealand, Norway, Panama, Poland, Reunion Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and United Kingdom
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.
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