Events

Recall of Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

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

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
    30145
  • Event Risk Class
    Class 2
  • Event Number
    Z-0018-05
  • Event Date Posted
    2004-10-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35249
  • 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
    Electrosurgical Electrode Kit - Product Code NWI
  • Reason
    Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ecg.
  • Action
    Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.

Device

Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
  • Model / Serial
    Serial Number:  MC02017-I3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.
  • Product Description
    Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
  • Manufacturer
    Datascope Corp

Manufacturer

Datascope Corp
  • Manufacturer Address
    Datascope Corp, 800 MacArthur Blvd, Mahwah NJ 07430-2001
  • Source
    USFDA