Z-0304-2007

4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D...

Name: Z-0304-2007 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D...
Creator: Varian Medical Systems Inc
Published: 2006-09-21
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2006-09-21 / Terminated / root cause: software

FDA source

Varian Medical Systems Inc began a recall of 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D Integrated treatment console versions 8.0.15 and below... on 2006-09-21. The reason FDA records is "Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient". 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-0304-2007
Status: Terminated
Initiated: 2006-09-21
Posted: 2006-12-19
Terminated: 2008-04-16
Recalling firm: Varian Medical Systems, Inc.
Product: 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, with Serial numbers H510946, H510651, H510190.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
Root cause tag: software
FDA root cause: Software design
Action: On September 21, 2006, the firm issued letters via certified mailing with return receipt to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Quantity in commerce: 1689 units
Distribution: Nationwide. Defense Supply Center, VA or other Federal Government sales/distribution centers include: V.A. Medical Center, Atlanta, Dept. of Radiation Oncology, 1670 Clairmont Rd., Decatur, GA, 30030; V.A. Medical Center of Long Beach, Dept. of Rad. Oncology, 5901 E. 7th St., Long beach, CA 90745; V.A. Medical Center, Department of Rad. Oncology, 4646 John R Street, Detroit, MI 48201; V.A. Medical Center-Jackson, Radiology Oncology, 1500 E. Woodrow-Wilson Ave., Jackson, MS 39216; V.A. West Los Angeles Medical Center, Dept., of Radiology Therapy, 11301 Wilshire Blvd., Building 345, Rm. 124, Los Angeles, CA 90073; V.A. Medical Center, 50 Irving Street NW, Washington, DC 20422; Blount Memorial Hospital, Radiology Oncology, 907 E. Lamar Alexander Pkwy., Maryville, TN 37804. Canadian distribution include: British Valley Cancer, 600 W. 10th Avenue, Vancouver, BC, V5Z 4E6, Canada; Fraser Valley Cancer, Radiology Oncology, 13750 96th Ave., Surrey, BC, V3V 1Z2, Canada; BHUM-Notre Dame Campus, Radiation Oncology Physics, 1560, Rue, Sherbrooke Est. Montreal, PQ, H2L 4M1, Canada. Other foreign distribution include: Australia, Austria, Bahrain, Belgium, Belorussia, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia & Montenegro, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam.
Product codes and lots: All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, with Serial numbers H510946, H510651, H510190

Product code IYE

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)