Z-2235-2014 Class II Terminated
FDA device recall Z-2235-2014 was initiated by Nellcor Puritan Bennett Inc. (dba Covidien LP) on July 17, 2014 and is designated Class II. 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 Vita… The recall status is terminated (terminated October 21, 2014). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2014
- Initiation Date
- July 17, 2014
- Termination Date
- October 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product 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.
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 Vital Sync system.
Distribution Pattern
US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
Code Information
Model # 10116080 ; Lot # PO643063