Food, drugs, devices › Mindray DS USA, Inc. dba Mindray North America
Device recall: DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, st
Mindray DS USA, Inc. dba Mindray North America (Mahwah, NJ) initiated this device recall on 5 Mar 2014; FDA lists 1 product record under event 67932, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 27 Apr 2015. Initiation: voluntary: firm initiated. Mindray DS USA, Inc. dba Mindray North America has 29 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ.
Reason for recall
"The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing."
Distribution
"US Nationwide Distribution in the state of OH"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1611-2014 | 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… | 4 units | Class II | Terminated | 21 May 2014 |
Context
Other enforcement events for Mindray DS USA, Inc. dba Mindray North America
All 29 events for Mindray DS USA, Inc. dba Mindray North America
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution in the state of OH"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Apr 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.