🔍 RecallPedia

Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.

Class I - Dangerous
🏥 Medical Devices Recalled: September 5, 2012 Mindray DS USA, Inc. d.b.a. Mindray North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mindray DS USA, Inc. d.b.a. Mindray North America
Reason for Recall:
Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.

Product Codes/Lot Numbers:

p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0742-2013

Related Recalls

Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.

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

Class I - Dangerous

Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.

Nov 28, 2012 Diagnostic Equipment Nationwide View Details →

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.

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

Class I - Dangerous

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.

May 12, 2011 Diagnostic Equipment Nationwide View Details →