Events

Recall of Device Recall Oridion Capnostream20

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oridion Capnography 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
    44926
  • Event Risk Class
    Class 2
  • Event Number
    Z-0177-2008
  • Event Initiated Date
    2007-07-28
  • Event Date Posted
    2007-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64535
  • 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
    Oximeter (Monitor) - Product Code DQA
  • Reason
    Handle cracking - cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
  • Action
    Oridion sent Dear Customer letters dated, August 21, 2007, informing users that a new monitor with the improved handle will be shipped by August 31, 2007.

Device

Device Recall Oridion Capnostream20
  • Model / Serial
    Serial Numbers: B200001085 B200001254 B200001163 B200001153 B200001150 B200001135 B200001133 B200001086 B200001105 B200001104 B200001103 B200001102 B200001101 B200001325 B200001258 B200001272 B200001275 B200001289 B200001290 B200001291 B200001323
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI,
  • Product Description
    Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical
  • Manufacturer
    Oridion Capnography Inc

Manufacturer

Oridion Capnography Inc
  • Manufacturer Address
    Oridion Capnography Inc, 160 Gould St, Needham Heights MA 02494-2313
  • Source
    USFDA