Events

Recall of Device Recall Capnostream20

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oridion Medical 1987 Ltd..

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
    52959
  • Event Risk Class
    Class 2
  • Event Number
    Z-2232-2009
  • Event Initiated Date
    2009-06-30
  • Event Date Posted
    2009-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84332
  • 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
    ventilator monitor - Product Code CCK
  • Reason
    1) the monitor's ability to withstand electrostatic discharge (esd) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) the unit generates electromagnetic radiation above the limits set by applicable standards for medical devices.
  • Action
    Oridian sent a letter to all its distributors June 25, 2009, instructing them to gather all the units to be exchanged for factory reconditioned units that have the hardware and software enhancements and meet all performance requirements in full.

Device

Device Recall Capnostream20
  • Model / Serial
    Software version V 3.0 and earlier.   Part Number Part Description   CS08651, Capnostream20 with Nellcor pulse oximetry module   CS08653 Capnostream20 with Masimo pulse oximetry module   CS08657 Capnostream20 with Nellcor pulse oximetry module and printer   CS08659  Capnostream20 with Masimo pulse oximetry module and printer
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.
  • Manufacturer
    Oridion Medical 1987 Ltd.

Manufacturer

Oridion Medical 1987 Ltd.
  • Manufacturer Address
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA