CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report
DPM 6 Monitor in use with a Multi Parameter Module (MPM) recalled
Mindray DS USA is recalling DPM 6 Monitor in use with a Multi Parameter Module (MPM), distributed nationwide in the US. The recall was initiated on 5 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1611-2014
- FDA event ID
- 67932
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2014
- FDA classified
- 12 May 2014
- Reported
- 21 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Temperature Abuse
- Device type
- Patient Monitors
Timeline
| 5 Mar 2014 | Recall initiated by company | |
| 12 May 2014 | Classified by FDA | +68 days |
| 21 May 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, 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)
Where it was distributed
US Nationwide Distribution in the state of OH
Questions about this recall
Why was it recalled?
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Which lots are affected?
monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876
Where was it sold?
US Nationwide Distribution in the state of OH
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mindray DS USA
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hardware configuration of the BeneVision Central Monitoring recalled | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | BeneVision N1 Patient Monitor (N1) recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS II | Sevoflurane E_Vap.(Quik-Fil):used recalled by Mindray DS USA | Mindray DS USA | Packaging Defects | 8 states |
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| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |