Recall Register

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Varian Medical Systems, Inc. Oncology Systems

FDA recalling firm · 9 enforcement events · 9 product records · 2011–2013 · CA

Varian Medical Systems, Inc. Oncology Systems has 9 FDA enforcement events on this register (9 product records) between 2011 and 2013: 9 device; the busiest year was 2012 with 6.

0% of its events are Class I; the most common class is Class II (9). 0 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
26 Mar 2013Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.DeviceClass II1Terminated
28 Jan 2013Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.DeviceClass II1Terminated
5 Nov 2012Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems…DeviceClass II1Terminated
24 Sep 2012ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.DeviceClass II1Terminated
17 Aug 2012Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients…DeviceClass II1Terminated
14 Aug 2012Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for…DeviceClass II1Terminated
2 Jul 2012Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management…DeviceClass II1Terminated
18 Jun 2012Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases.…DeviceClass II1Terminated
31 May 2011Varian 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…DeviceClass II1Terminated

By type and class

Device9
Class II9

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

11
13
15
17
19
21
23
25
Enforcement events for Varian Medical Systems, Inc. Oncology Systems by year initiated.

Questions and answers

How many FDA recalls has Varian Medical Systems, Inc. Oncology Systems had?

9 enforcement events (9 product records) on this register, 2011–2013: 9 device.

Are any Varian Medical Systems, Inc. Oncology Systems recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Varian Medical Systems, Inc. Oncology Systems recalls?

9 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.