[Recalled] 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 ana
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 oxy |
|---|---|
| Brand / manufacturer | Mindray DS USA, Inc. dba Mindray North America |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1611-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 March 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Mindray DS USA, Inc. dba Mindray North America
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.