Events

Recall of Device Recall Mindray DS USA, Inc. 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 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
    67495
  • Event Risk Class
    Class 2
  • Event Number
    Z-1156-2014
  • Event Initiated Date
    2014-01-08
  • Event Date Posted
    2014-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125558
  • 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
    Mindray has identified two issues with the panorama central station. full disclosure data may lag behind the panorama system time clock when the panorama central station is in use with mindray¿s v-series monitor. additionally, event indicators lag behind the panorama system time clock when the panorama central station is in use with a panorama telepack.
  • Action
    Mindray DS USA Inc. sent an Urgent Corrective Action letter dated January 8, 2014 via certified mail to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact Mindray Service Representative, at 1-800-288-2121 (Monday  Friday 8:30 am-5:30 pm), to arrange for the software update of the Panorama System(s) in their facility. This work will be performed at no cost.

Device

Device Recall Mindray DS USA, Inc. Panorama Patient Monitoring Network
  • Model / Serial
    p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide Distribution
  • Product Description
    Panaroma Central Station || Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set 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