DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA — Class II medical device recall Z-0513-2013
Terminated recall by Mindray DS USA, Inc. d.b.a. Mindray North America, reported 2012-12-19, distributed nationwide. There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Dis
| Recall number | Z-0513-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2010-08-11 |
| Classified | 2012-12-11 |
| Reported by FDA | 2012-12-19 |
| Terminated | 2013-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 124 units |
Product
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).
Reason for recall
There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.