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.
This recall has been terminated (originally issued December 19, 2006).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- September 21, 2006
- Posted
- December 19, 2006
- Terminated
- April 16, 2008
- Recall Number
- Z-0304-2007
- Quantity
- 1689 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
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 / Code Info
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
Root Cause
Software design
Action Taken
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.