Events

Recall of Device Recall DPM Central Station

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc. d.b.a. 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
    63616
  • Event Risk Class
    Class 2
  • Event Number
    Z-0630-2013
  • Event Initiated Date
    2011-05-12
  • Event Date Posted
    2013-01-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114367
  • 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
    System,network and communication,physiological monitors - Product Code MSX
  • Reason
    There is a software anomaly with the dpm central monitoring system where the trend data of one patient maybe replaced with the trend data of a second patient.
  • Action
    Mindray sent a Product Corrective Action letter dated May 12, 2012, to all affected customers via certified mail return receipt requested to two medical facilities. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the issue would be corrected through a softweare upgrade of the affected product. A Mindray Service Representative would contact their facility to arrange for the software upgrade at no cost to them. For questions regarding this recall call 1-800-288-2121.

Device

Device Recall DPM Central Station
  • Model / Serial
    510 K K080192 P/N 300BF-PA200002
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including OH and GA
  • Product Description
    DPM Central Station || Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 || The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
  • Manufacturer
    Mindray DS USA, Inc. d.b.a. Mindray North America

Manufacturer

Mindray DS USA, Inc. d.b.a. Mindray North America