Events

Recall of LIFEDOP 250 SYSTEM - PROBES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES.

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
    17960
  • Event Risk Class
    III
  • Event Initiated Date
    2017-10-06
  • 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 coopersurgical 2 mhz waterproof ob probe is for obstetrical use in the labor and delivery department for late term obstetrical examination associated with larger women. the product detects fetal heart beats as an aid for determining fetal viability. coopersurgical quality assurance program identified that the 2mhz is incorrectly labeled with the 3 mhz probe label on september 19 2017. the event was discovered internally during product complaint investigation.

Device

LIFEDOP 250 SYSTEM - PROBES

Manufacturer

COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES