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

FDA Device Recall #Z-0742-2013 — Class II — September 5, 2012

Recall Summary

Recall Number Z-0742-2013
Classification Class II — Moderate risk
Date Initiated September 5, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mindray DS USA, Inc. d.b.a. Mindray North America
Location Mahwah, NJ
Product Type Devices
Quantity 13 units

Product Description

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

Reason for Recall

Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.

Distribution Pattern

US Nationwide Distribution including the states of: VA, TN, FL, & TX

Lot / Code Information

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

Other Recalls from Mindray DS USA, Inc. d.b.a. Mindray N...

Recall # Classification Product Date
Z-0977-2013 Class II BS-200 Chemistry Analyzer Designed for clini... Nov 28, 2012
Z-0798-2013 Class II Mindray DS USA, Inc., DPM Central Monitoring Sy... Nov 28, 2012
Z-0528-2013 Class II Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.... Sep 24, 2012
Z-0291-2013 Class I Mindray A5 Anesthesia Delivery System Manufac... Aug 13, 2012
Z-0290-2013 Class I Mindray A3 Anesthesia Delivery System Manufac... Aug 13, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.