FDA Device recall Z-2235-2014
Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device by Nellcor Puritan Bennett Dba Covidien, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2235-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-17 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nellcor Puritan Bennett Dba Covidien |
| Distribution | CA, CO, GA, IL, IN, LA, MS, TX |
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.
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.
Identifiers
| code_info | Model # 10116080 ; Lot # PO643063 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2235-2014%22
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