Drug recall
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm…
FDA recall event 70959 · Class II · Mindray DS USA, Inc. dba Mindray North America
Key facts
| Event ID | 70959 |
|---|---|
| Recall numbers | Z-1675-2015 |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America |
| Product type | Devices |
| Products | Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously displayed on both the… |
| Initiation date | Mar 12, 2015 |
| Report date | Jun 3, 2015 |
| Termination date | Mar 28, 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: