Recall StatusTerminated
Date Initiated2018-08-20
Date Terminated2020-08-28
Product Quantity387
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.
Firm 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
[email protected].
Root Cause
Software design
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.