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.
Enforcement
- Recall Number
- Z-2235-2014
- Event ID
- 68802
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 20, 2014
- Initiation Date
- July 17, 2014
- Classification Date
- August 14, 2014
- Termination Date
- October 21, 2014
- Address
- 6135 Gunbarrel Ave, N/A, Boulder, CO, 80301-3214, United States
Description
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.
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.
Model # 10116080 ; Lot # PO643063
US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
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