FDA Medical Device Recalls (openFDA)
Varian Medical Systems Inc: 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.
- Recall number
- Z-0304-2007
- 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.
- Status
- Terminated
- Initiated
- 2006-09-21
- Posted
- 2006-12-19
- Terminated
- 2008-04-16
- Reason
- Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K001643","K050479"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28