Events

Safety Alert for SPY-PHI Drape

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Novadaq Technologies Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-06-28
  • Event Date Posted
    2017-06-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170628c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: novadaq technologies inc. spy-phi drape medical device manufacturer, novadaq technologies inc., has issued a medical device safety alert concerning its spy-phi drape. the affected model numbers are hh2000 and hh2020. according to the manufacturer, a pinhole through the drape material was identified following use of a drape in a surgical procedure. while there have been no reports of infection submitted to the manufacturer as a result of the drape material integrity being compromised, a remote possibility exists that a compromised drape may cause harm to a patient through infection. product recall is on-going. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 june 2017.

Device

SPY-PHI Drape
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Novadaq Technologies Inc. SPY-PHI Drape
  • Manufacturer
    Novadaq Technologies Inc.

Manufacturer

Novadaq Technologies Inc.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH