Class 2 Device Recall Varian

• Date Initiated by Firm: March 26, 2013
• Date Posted: April 23, 2013
• Recall Status: Terminated on July 09, 2014
• Recall Number: Z-1163-2013
• Recall Event ID: 64828
• 510(K)Number: K102024
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2; ; Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
• Code Information: CODES: HS00017 HS00366 HS00611 HS00804 HS01060 HS01256 HS01451 HS01662 HS01863 HS02024 HS02215 HS02371 HS02539 HS00018 HS00371 HS00615 HS00805 HS01061 HS01260 HS01456 HS01664 HS01872 HS02035 HS02239 HS02373 HS02542 HS00025 HS00378 HS00618 HS00806 HS01062 HS01265 HSOI459 HSOI667 HSOI875 HS02040 HS02240 HS02376 HS02545 HS00026 HS00384 HS00619 HS00807 HSOI063 HSOI269 HSOI460 HSOI671 HSOI876 HS02043 HS02242 HS02377 HS02548 HS00031 HS00385 HS00624 HS00811 HSOI066 HS01270 HSOI462 HSOI674 HSOI877 HS02048 HS02245 HS02380 HS02SSI HS00032 HS00392 HS00628 HS00813 HS01069 HSOI281 HS01463 HSOI675 HSOI878 HS02053 HS02250 HS02381 HS02553 HS00035 HS00393 HS00630 HS00814 HS01071 HSOI282 HS01466 HS01676 HS01883 HS020SS HS022Sl HS02383 HS02554 HS00036 HS00396 HS00634 HSOOSIS HS01080 HS01283 HS0147l HS01678 HS01885 HS02059 HS02253 HS02384 HS02SSS HS00037 HS00398 HS00636 HS00818 HSOIOSS HS01285 HS01480 HS01685 HS01886 HS02068 HS02256 HS02389 HS02562 HS00038 HS00408 HS00638 HS00827 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• Recalling Firm/ Manufacturer: Varian Medical Systems, Inc. Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: Patricia A. Erwin; 650-424-5731
• Manufacturer Reason for Recall: Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
• FDA Determined Cause: Device Design
• Action: Varian sent an Urgent Medical Device Correction - Urgent Field Safety Notice Letter dated March 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain a copy of this document along with their most current product labeling, advise the appropriate personnel of the content of this letter, and for future reference this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. The letter stated that a Varian Medical Systems has developed a technical correction and a Customer Service representative will contact customers to schedule installation. For question contact your local Varian medical Systems Customer Support District or Regional Manager.
• Quantity in Commerce: 2508 units
• Distribution: Worldwide Distribution - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab E, 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