Events

Safety Alert for Alaris PC unit model 8015 with software version 9.12

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

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
    2013-04-26
  • Event Date Posted
    2013-04-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426d.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: carefusion alaris pc unit model 8015 with software version 9.12 the united states food and drug administration (fda) has posted a medical device safety alert issued by medical device manufacturer, carefusion corporation, concerning its alaris pc unit model 8015 with software version 9.12. according to the manufacturer, the recall was initiated because the manufacturer has received reports of a communication error on the alaris pc unit model 8015 with software version 9.12 when the alaris etco2 module or alaris spo2 module is attached. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm? action=select&recall_number=z-1098-2013&w=04242013&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

Alaris PC unit model 8015 with software version 9.12

Manufacturer

Carefusion Corporation