Device Recall VARiS

  • Model / Serial
    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 Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304-1038
  • Source
    USFDA

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    JAQ
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
  • Manufacturer
  • Model / Serial
    Model #: 00711819; Lot 1520268
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
  • Product Description
    Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 || A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
  • Manufacturer
  • Model / Serial
    All Lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela
  • Product Description
    VariSource AL 13199023 Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons: 20/PKG
  • Manufacturer
  • Model / Serial
    All Lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela
  • Product Description
    VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable
  • Manufacturer
  • Model / Serial
    All Lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela
  • Product Description
    VariSource AL 13197000, Tongue/Soft Tissue Kit
  • Manufacturer
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