CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
VitalBeam Radiotherapy Delivery System recalled
Varian Medical Systems is recalling VitalBeam Radiotherapy Delivery System, distributed nationwide in the US. The recall was initiated on 20 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0005-2019
- FDA event ID
- 81010
- Recalling firm
- Varian Medical Systems, Palo Alto, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Aug 2018
- FDA classified
- 1 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Aug 2018 | Recall initiated by company | |
| 1 Oct 2018 | Classified by FDA | +42 days |
| 10 Oct 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMissouriNew HampshireNew JerseyNew YorkOhioOklahoma
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81010| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | TrueBeam Radiotherapy Delivery System recalled by Varian Medical Systems | Varian Medical Systems | Other | Nationwide |
More recalls from Varian Medical Systems
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Varian Multileaf Collimator [MLC] recalled by Varian Medical Systems | Varian Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Eclipse(TM) Treatment Planning System recalled by Varian Medical Systems | Varian Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | TrueBeam Radiotherapy Delivery System recalled by Varian Medical Systems | Varian Medical Systems | Other | Nationwide |
| Device | CLASS II | Eclipse Treatment Planning System recalled by Varian Medical Systems | Varian Medical Systems | Other | FL, NJ, TN |
| Device | CLASS II | Varian Head Frame recalled by Varian Medical Systems | Varian Medical Systems | Foreign Material | CA |
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