Device Recall Clinac 21EXS Sihlouette

  • Model / Serial
    Affected Serial Numbers: H140001, H140002, H140003, H140004, H140005, H140006, H140007, H140009, H140022, H140010, H14001, H140012, H140013, H140014, H140015, H140016, H140017, H140018, H140019, H140021, H140023, H140024, H140025.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution is: CA, CT, IL, IN, KY, OH, MI, NC, NJ, NY, SC, TN, TX, VA, & WA, totaling 22 hospitals. Foreign distribution includes: Denmark, Hong Kong, and Japan. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.
  • Product Description
    Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); || Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Varian Medical Systems Inc, 3100 Hansen Way, M/S E-210, Palo Alto CA 94304
  • Source
    USFDA