Events

Recall of SDC PRO 2 - DVD VERSION CAPTURE RECORDER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

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
    46822
  • Event Risk Class
    II
  • Event Initiated Date
    2009-12-23
  • 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
    Stryker endoscopy has become aware that the sdc pro 2 picture/video capture device will not be able to assign the correct time/date stamp for saved files after 31 december 2009. on january 1st 2010 the system date for all sdc pro 2 units will re-start from october 1st 2001 and begin incrementing from that point onwards. this problem will not affect how pictures or videos are captured using sdc pro 2 during surgery. the system date will be incorrect and users will not be able to correct this issue.

Device

SDC PRO 2 - DVD VERSION CAPTURE RECORDER
  • Model / Serial
    Model Catalog: 240-050-810 (Lot serial: ALL)
  • Product Description
    SDC PRO 2
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC