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Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are
Recalled August 20, 2014 · FDA recall Z-2235-2014 · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Hazard
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 Vital Sync system. · FDA Class II
Units
9
Sold at
US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
Description
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 Vital Sync system.
Product
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 Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
Manufacturer(s)
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →