Events

Recall of Device Recall Mindray DS USA

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 Mindray North America.

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
    73693
  • Event Risk Class
    Class 2
  • Event Number
    Z-1575-2016
  • Event Initiated Date
    2016-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144763
  • 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
    Panorama central station including the work station view station, view station and the egateway will revert to the year 2000 when daylight savings time (dst) occurs on march 13, 2016, or under various conditions.
  • Action
    Mindray DS USA Inc. issued a Medical Device Service Notice dated March 9, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers requiring technical assistance were instructed to contact Mindray's Technical Support team at 1-800-288-2121. Mindray will address the systems response to DST in a future software update which will be provided to the customer at no cost.

Device

Device Recall Mindray DS USA
  • Model / Serial
    Panorama Central Station's CPU Unit, Tower (p/n 0998-00-0709-01) Panorama Central Station's CPU Unit, 2U case (p/n 0998-00-0708-01) Panorama Centrall Station's eGateway Tower (p/n 0998-00-0709-03) Panorama Central Station's eGateway 2U case (p/n 0998-00-0708-03)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Panorama Patient Monitoring Network || Mindray DS USA || The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America