Drug recall
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra…
FDA recall event 62880 · Class II · Mindray DS USA, Inc. d.b.a. Mindray North America
Key facts
| Event ID | 62880 |
|---|---|
| Recall numbers | Z-2279-2012 |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Product type | Devices |
| Products | V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series… |
| Initiation date | May 7, 2012 |
| Report date | Sep 5, 2012 |
| Termination date | Jul 17, 2013 |
| 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: