DPM 6 Monitor in use with a Multi Parameter Module — Class II medical device recall Z-1611-2014
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2014-05-21, distributed nationwide. The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
| Recall number | Z-1611-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2014-03-05 |
| Classified | 2014-05-12 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2015-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Reason classes | unapproved product |
Product
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)
Reason for recall
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1611-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.