Events

Recall of Nonin Cerebral Oximeter Pod

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nonin Medical, 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
    53801
  • Event Risk Class
    Class 2
  • Event Number
    Z-0458-2010
  • Event Initiated Date
    2009-10-23
  • Event Date Posted
    2009-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86537
  • 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
    Tissue Saturation Oximeter - Product Code MUD
  • Reason
    A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the pod. this overheating, while unlikely to occur, has the potential to cause a burn if the pod is in direct contact with the patient.
  • Action
    An Urgent: Medical Device Recall letter was emailed to customers on 10/23/2009. The letter described the issue and hazard and asked that the use of the device be discontinued and to immediately contact Nonin for return and repair/replacement instructions. Questions or concerns should be directed to John Dalpee at 763-577-3166.

Device

Nonin Cerebral Oximeter Pod
  • Model / Serial
    Serial numbers: 500814470, 500814472, 500814474, 500814478, 500814480, 500814484, 500823139, 500823145, 500823146, 500823154, 500823159, 500823161, 500823164, 500823166, 500823172, 500823174, 500823175, 500823176, 500823181, 500823182, 500849316, 500849318, 500849321, 500849325, 500849331, 500849333, 500849336, 500849337, 500849338, 500849342, 500849343, 500849344, 500849347, 500849348, 500849349, 500849350, 500849351, 500849353, 500849356, 500849357, 500849358, 500849360, 500849361, 500849366, 500849367, 500849368, 500849369, 500849370, 500849372, 500849373, 500849375, 500849378, 500849380, 500849386, 500849387, 500849388, 500849389, 500849390, 500857060, 500857061, 500857064, and 500874926.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of LA, MN, NC, and NY and countries of Canada, Germany, Italy, Netherlands, and United Kingdom.
  • Product Description
    Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.
  • Manufacturer
    Nonin Medical, Inc

Manufacturer

Nonin Medical, Inc
  • Manufacturer Address
    Nonin Medical, Inc, 13700 1st Ave N, Plymouth MN 55441
  • Manufacturer Parent Company (2017)
    Nonin Medical, Inc.
  • Source
    USFDA