Events

Recall of Panorama Patient Monitoring Network

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc., dba Datascope Patient Monitoring.

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
    51863
  • Event Risk Class
    Class 2
  • Event Number
    Z-1401-2009
  • Event Initiated Date
    2009-04-10
  • Event Date Posted
    2009-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81474
  • 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 Patient Monitor (With Arrhythmia Detection or Alarms) - Product Code MHX
  • Reason
    Software anomaly: software anomaly can occur when the panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.
  • Action
    Urgent Product Field Correction letters, dated March 27, 2009, were sent by certified mail, return requested, and signature required. The letters identified the affected product and the problem. It also stated the adverse effect on patients and that customers' Panorama software will be upgraded to a current software revision. A Datascope Service Representative will contact customers to arrange for the software upgrade of the Panorama(s) in their facility. This will be done at no cost to the customer.

Device

Panorama Patient Monitoring Network
  • Model / Serial
    Software version 8.5.5, 8.5.6, 8.6.1, or 8.7.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Australia.
  • Product Description
    Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. || Datascope Patient Monitoring || Intended for use in a fixed location, in the healthcare facility setting, as a central viewing station.
  • Manufacturer
    Mindray DS USA, Inc., dba Datascope Patient Monitoring

Manufacturer

Mindray DS USA, Inc., dba Datascope Patient Monitoring