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Terminated

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.

FDA Recall Z-0304-2007 · Posted 2006-12-19

Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2006-09-21
Date Terminated2008-04-16
Product Quantity1689 units

Reason for Recall

Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0504794D INTEGRATED TREATMENT CONSOLEVarian Medical Systems · 2005-03-24K001643VARIS 1.4GVarian Medical Systems, Inc. · 2000-06-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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