Events

Recall of Device Recall Radiance Flex Blood Gas Anayzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America Inc.

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
    36539
  • Event Risk Class
    Class 2
  • Event Number
    Z-0115-2007
  • Event Initiated Date
    2006-07-06
  • Event Date Posted
    2006-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48877
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Blood Gas Analyzer - Product Code JQP
  • Reason
    Incorrect fi02 values: programming issue can cause incorrect values to be transmitted to the lis when : 1)- the fio2 result is edited in the manual sample processing mode--2)- an existing result is opened and fi02 is then edited and sent.....In both cases radiance will transmit the original fi02 value, not the value that was edited.
  • Action
    The recalling firm initially contacted their customers and informed them of the software problem and the upcoming field correction for the software, via telephone on 7/6/2006. A follow-up letter dated 7/21/2006, was also sent to the customers.

Device

Device Recall Radiance Flex Blood Gas Anayzer
  • Model / Serial
    Catalog Numbers: 914-418 and 914-426
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-The six USA units (equpped with Radiance software) were distributed to a total of two (2) U.S. customers: University of Missouri Hospitals and Clinics in Columbia, MO (4 units) and Vail Valley Medical Center, Vail, CO (2 units). World wide accounts pending submission. Three (3) Canadian customers. They are: 1) Seven Oaks General Hospital MB Canada; and 2) St. Mary''s General Hospital, 911 Queens Blvd, Ontario Canada; and 3) University of Alberta Hospital, 84440 112th Street, Alberta, Canada.
  • Product Description
    Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA