Z-0393-06

Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2...

Name: Z-0393-06 Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2...
Creator: Varian Medical Systems Inc
Published: 2005-11-23
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2005-11-23 / Terminated

FDA source

Varian Medical Systems Inc began a recall of 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)... on 2005-11-23. The reason FDA records is "The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0393-06
Status: Terminated
Initiated: 2005-11-23
Posted: 2006-01-18
Terminated: 2006-07-05
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
Product code: IWB System, Radiation Therapy, Radionuclide
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.
FDA 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.
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.
Product codes and lots: 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

Product code IWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)