FDA Medical Device Recalls (openFDA)
Varian Medical Systems Inc: 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
- Recall number
- Z-0393-06
- Recalling firm
- Varian Medical Systems Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2005-11-23
- Posted
- 2006-01-18
- Terminated
- 2006-07-05
- Reason
- The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.
- Root cause
- Other
- Action
- On 11/23/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
- Quantity
- not on file
- 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, serial or model codes
- 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
- 510(k) numbers
- ["K010975","K023052","K932501"]
- PMA numbers
- not on file
- Product code
- IWB
- 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