Events

Recall of Panorama

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

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
    45405
  • Event Risk Class
    Class 2
  • Event Number
    Z-0150-2008
  • Event Initiated Date
    2007-10-09
  • Event Date Posted
    2008-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65387
  • 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
    Physiological Monitor - Product Code MHX
  • Reason
    Display problems: if an ecg cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with the telepack, it may cause the telepack to switch between the 3-lead and 5 lead-input modes. during the switching process, the digital heart rate displayed at the panorama central station will be frozen, and subsquent arrthymia alarms will not be announced.
  • Action
    Urgent Product Field Correction notices were sent to hospital administrators on October 9, 2007, by certified mail, return receipt requested. The letter describes the scenario that causes the problem and its remediation It also describes how the software upgrade will fix the problem and alerts hospitals that a Datascope Service Representative will be contacting them to arrange for the upgrade.

Device

Panorama
  • Model / Serial
    Part Number 0998-00-0191-04
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Manufacturer Address
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA