Z-0005-2019Class II

VitalBeam Radiotherapy Delivery System Version 2.5

Name: Z-0005-2019 VitalBeam Radiotherapy Delivery System Version 2.5
Creator: Varian Medical Systems
Published: 2018-08-20
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2018-08-20 / Terminated / root cause: software

FDA source

Varian Medical Systems began a recall of VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and... on 2018-08-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0005-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-20
Posted: 2018-10-01
Terminated: 2020-08-28
Recalling firm: Varian Medical Systems, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: 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 [email protected].
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0005-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0004-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-0005-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01

Product code IYE

K150706Class IIVitalBeamVarian Medical Systems, Inc. / cleared 2015-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)