Events

Recall of Mindray DS USA Inc.

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
    63800
  • Event Risk Class
    Class 2
  • Event Number
    Z-0742-2013
  • Event Initiated Date
    2012-09-05
  • Event Date Posted
    2013-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114790
  • 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(without arrhythmia detection or alarms) - Product Code MWI
  • Reason
    Mindray has identified an issue with the dpm5 monitors where st and arrhythmia features may not be available.
  • Action
    Mindray DS USA Inc. sent an Urgent Product Corrective Action letter on September 5, 2012 via Fed Ex with delivery confirmation to all users. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday 8:30-5:30 pm, to schedule a software upgrade.

Device

Mindray DS USA Inc.
  • Model / Serial
    p/n 9201F-PA000XX  DS-  0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including the states of: VA, TN, FL, & TX
  • Product Description
    Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
  • Manufacturer
    Mindray DS USA, Inc. d.b.a. Mindray North America

Manufacturer

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