Events

Recall of Device Recall AUDICOR 200 D

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inovise 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
    34472
  • Event Risk Class
    Class 2
  • Event Number
    Z-0565-06
  • Event Initiated Date
    2003-01-12
  • Event Date Posted
    2006-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43901
  • 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
    Electrocardiograph - Product Code DPS
  • Reason
    Use of the audicor 200 d in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the audicor 200 d stopped working due to low battery power.
  • Action
    On January 12, 2006, 2 of 3 customers were notified by telephone, with follow-up email. All three customers were visited by the firm on January 16-17, 2006. Customers were instucted to not use the device in-line with a defibrillator/monitor.

Device

Device Recall AUDICOR 200 D
  • Model / Serial
    Serial Numbers: 411005, 411007, 411008, 411010, 411011, 411013, 411014, 411015, 411016, 411017, 411018, 411019, 411020, 411023, 411024, 411025, 411026, 411030, 411031, 411032, 411033, 411047, 411048, 411049, 411051, 411052, 411053, 411054.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed to three EMS/Fire Departments located in Florida and Washington
  • Product Description
    AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).
  • Manufacturer
    Inovise Medical, Inc.

Manufacturer

Inovise Medical, Inc.
  • Manufacturer Address
    Inovise Medical, Inc., 10565 Sw Nimbus Ave Ste 100, Portland OR 97223-4311
  • Source
    USFDA