Events

Recall of Device Recall Clinac 21EXS Sihlouette

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    31633
  • Event Risk Class
    Class 2
  • Event Number
    Z-1530-05
  • Event Initiated Date
    2005-03-30
  • Event Date Posted
    2005-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38272
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, Linear, Medical - Product Code IYE
  • Reason
    Emergency off switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.
  • Action
    On 3/16/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.

Device

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
    Radiology Devices
  • 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
    Varian Medical Systems Inc

Manufacturer

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