Food, drugs, devices › Varian Medical Systems, Inc. Oncology Systems
Device recall: ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a tre
Varian Medical Systems, Inc. Oncology Systems (Palo Alto, CA) initiated this device recall on 24 Sep 2012; FDA lists 1 product record under event 63471, 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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 5 Dec 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
"An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued."
Distribution
"Worldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0187-2013 | ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. | 205 | Class II | Terminated | 7 Nov 2012 |
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: "An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued."
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 - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Dec 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.