Events

Recall of OPTICAL GUIDANCE PLATFORM - SONARRAY MODULE

According to Health Canada (via FOI), this recall involved a device in Canada 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
    131453
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations. the optical guidance camera has not been evaluated for stability beyond a 24 hour time period and must be recalibrated at least once every 24 hours. this issue is most likely to be found in units upgraded to the 2.6.X software as older versions of the software allowed users to set calibration time outs greater than 24 hours. however all users should check their settings as described. in particular this issue may be found in sonarray systems where users may have increased the calibration time out beyond the factory settings.

Device

OPTICAL GUIDANCE PLATFORM - SONARRAY MODULE
  • Model / Serial
    Model Catalog: 97530203A (Lot serial: NZ17010); Model Catalog: 97530203A (Lot serial: HZ19078); Model Catalog: 97530203A (Lot serial: HZ12066)
  • Product Description
    OPTICAL GUIDANCE PLATFORM - SONARRAY MODULE
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.