FDAFDA · Food and drugs·Recall number Z-2235-2014
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.
Published August 20, 2014 · Recall initiated: July 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Distributor
- US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
- Lot
- Model # 10116080 ; Lot # PO643063
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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