Drug recall
Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device…
FDA recall event 68802 · Class II · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Key facts
| Event ID | 68802 |
|---|---|
| Recall numbers | Z-2234-2014, Z-2235-2014 |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Product type | Devices |
| Products | Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual…, Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the… |
| Initiation date | Jul 17, 2014 |
| Report date | Aug 20, 2014 |
| Termination date | Oct 21, 2014 |
| City | Boulder |
| State | CO |
| Country | United States |
| FEI number | 2936999 |
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: