Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acuity (used with BrainLab M3 MLC); Product Number 83 (used with Product Number 53); Product Number 48 (used with Product Number 53); Product Number 77 (used with Product Number 53); Product is distributed by Varian Medical Systems, 911 Hansen Way, Palo Alto, CA 94304
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- November 23, 2005
- Posted
- January 18, 2006
- Terminated
- July 5, 2006
- Recall Number
- Z-0393-06
- Firm Location
- Palo Alto, CA
Reason for Recall
The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.
Distribution
Worldwide to 219 accounts. U.S. States: AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV. 118 accounts Foreign consignees include Netherlands, Thailand, Taiwan, R.O.C., Sweden, Spain, South Korea, South Africa, Slovenia, Singapore, Saudi Arabia, Russian Fed., Portugal, Poland, Philippines, Mexico, Malaysia, Japan, Italy, Israel, India, Hong Kong, Germany, France, Finland, Egypt, Denmark, Czech Republic, China, Canada, Brazil, Belgium, Austria, and Australia.
Lot / Code Info
H530338, H531026, H532001, H532024, H541335, H532011, H531018, H530104, H532027, H530309, H530321, H530323, H531034, H531995, H530204, H541198, H531038, H530427, H532036, H530313, H530250, H532025, H530064, H530009, H530093, H530311, H530042, H530231, H530316, H530084, H530065, H530022, H530029, H530340, H530302, H532023, H530059, H531037, H530396, H530080, H532038, H530333, H530408, H531024, H530032, H530025, H530414, H530051, H530052, H530310, H533006, H530324, H530419, H530056, H531040, H531043, H531033, H530086, H532028, H532010, H530433, H532035, H531044, H532020, H531039, H535018, H531017, H530078, H532002, H530406, H532019, H530334, H531002, H530019, H532031, H530107, H530066, H530075, H530417, H532015, H533001, H530001, H530018, H530033, H531036, H530402, H534223, H530017, H530011, H530434, H533020, H530074, H530428, H530339, H530425, H530031, H532026, H531031, H531001, H533035, H530050, H530024, H530439, H531470, H531487, H532032, H534015, H530039, H531838, H532022, H533018, H530437, H530030, H532006, H533008, H535009, H533015, H534021, H534022, H534032, H530061, H532037, H530028, H531010, H531028, H535012, H532039, H530013, H530073, H530330, H533030, H534004, H534040, H530085, H533027, H534036, H532005, H530430, H530435, H531029, H530023, H530035, H530036, H530037, H530038, H530045, H530049, H530063, H530126, H530401, H530409, H530410, H530429, H530441, H531020, H531021, H532042, H533036, H535001, H535008, H531035, H531041, H532014, H533004, H535003, H535004, H530014, H533014, H530012, H530021, H530337, H531023, H533037, H530004, H530008, H530027, H530047, H530055, H530068M, H530068R1, H530072, H531008, H532013, H533032, H530087, H533028, H533029, H534026, H535002, H535013, H531025, H532021, H534020, H530081, H532007, H530057, H530076, H533043, H530043, H530405, H531042, H531345, H532004, H532016, H530052, H530104, H530402, H530427, H531044, H530034, H530218, H535015, H530048, H530423, H530005, H530046, H532029, H530319, H535005
Root Cause
Other
Action Taken
On 11/23/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.