Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Date of Enforcement Report: 8/27/2014
Class lI:
PRODUCT
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 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.
Recall Number Z-2234-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder COon 7/17/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
3
DISTRIBUTION
Nationwide
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