Events

Recall of CAMINO ADVANCED MONITOR

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

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
    26729
  • Event Risk Class
    III
  • Event Initiated Date
    2013-11-20
  • 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
    Integra lifesciences has identified that if the optional sys/dias mode is used on camino advanced monitors (cam01) with serial numbers formatted as mexxxxx04 the displayed values for the systolic and diastolic intracranial pressure (icp) are reversed. but if the cam01 is used with an auxiliary bedside monitor the bedside monitor displays these values correctly.

Device

CAMINO ADVANCED MONITOR
  • Model / Serial
    Model Catalog: CAM01 (Lot serial: MED1301104); Model Catalog: CAM01 (Lot serial: MED1301204); Model Catalog: CAM01 (Lot serial: MEE1300504); Model Catalog: CAM01 (Lot serial: MEC1300404); Model Catalog: CAM01 (Lot serial: MEA1301804); Model Catalog: CAM01 (Lot serial: MEE1301504); Model Catalog: CAM01 (Lot serial: MED1301304)
  • Product Description
    CAMINO ADVANCED MONITOR
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.