Food, drugs, devices › Varian Medical Systems, Inc. Oncology Systems
Device recall: Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Prod
Varian Medical Systems, Inc. Oncology Systems (Palo Alto, CA) initiated this device recall on 31 May 2011; FDA lists 1 product record under event 64997, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 114 device enforcement events initiated in 2011 carry the same class.
Status: Terminated, terminated 15 May 2013. Initiation: voluntary: firm initiated. Varian Medical Systems, Inc. Oncology Systems has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA.
Reason for recall
"Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control."
Distribution
"Worldwide distribution - USA (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Australia, Austria, Bahrain, Bangladesh, Belarus, Belguim, Brazil, Bosnia and Hezregovina,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1325-2013 | Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation… | 3943 units | Class II | Terminated | 22 May 2013 |
Context
Other enforcement events for Varian Medical Systems, Inc. Oncology Systems
All 9 events for Varian Medical Systems, Inc. Oncology Systems
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - USA (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Australia, Austria, Bahrain, Bangladesh, Belarus, Belguim, Brazil, Bosnia and Hezregovina,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 May 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.