Drug recall
Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within…
FDA recall event 66996 · Class II · Medrad Mr Inc
Key facts
| Event ID | 66996 |
|---|---|
| Recall numbers | Z-0810-2014 |
| Recalling firm | Medrad Mr Inc |
| Product type | Devices |
| Products | Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs… |
| Initiation date | Nov 21, 2013 |
| Report date | Jan 29, 2014 |
| Termination date | Mar 30, 2015 |
| City | Warrendale |
| State | PA |
| Country | United States |
| FEI number | 3008836473 |
At a glance
- 1–9 Products in this recall
- None 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: