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
    32617
  • Event Risk Class
    Class 2
  • Event Number
    Z-1104-05
  • Event Initiated Date
    2005-06-16
  • Event Date Posted
    2005-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40447
  • 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, Cardiac (Incl. Cardiotachometer & Rate Alarm) - Product Code DRT
  • Reason
    Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.
  • Action
    The firm sent a field correction communications to all customers via certified mail on 6/10/2005. A Datascope Service Representative will conduct and document this corrective action during a visit to the customer.

Device

Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
  • Model / Serial
    All units currently out in the market.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There were 68 domestic customers nationwide and 2 international customers in Belgium and Italy.
  • 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