Drug recall
DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is…
FDA recall event 69788 · Class II · Mindray DS USA, Inc. dba Mindray North America
Key facts
| Event ID | 69788 |
|---|---|
| Recall numbers | Z-0837-2015 |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America |
| Product type | Devices |
| Products | DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display. |
| Initiation date | Oct 6, 2014 |
| Report date | Dec 31, 2014 |
| Termination date | Jun 6, 2017 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 2221819 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: