Events

Recall of Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

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
    34320
  • Event Risk Class
    Class 2
  • Event Number
    Z-0437-06
  • Event Initiated Date
    2005-12-07
  • Event Date Posted
    2006-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43529
  • 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
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
  • Reason
    Software anomaly that affects the panorama telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
  • Action
    Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer.

Device

Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
  • Model / Serial
    All Panorama Central Station containing software versions 8.1.6 - 8.2
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to hospitals and clinics nationwide. There is one US Government account, VA Medical Center, Birmingham, AL.
  • Product Description
    Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
  • Manufacturer
    Datascope Corp

Manufacturer

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