Vital Sync Virtual Patient Monitoring Platform software recall for alarm mismatch
Nellcor Puritan Bennett Inc. is recalling Vital Sync software due to a mismatch between alarm priorities on medical devices and the monitoring system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that affects alarm priorities, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Nellcor Puritan Bennett Inc. (dba Covidien LP) is conducting a field correction for the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager software, version 2.4. The software is packaged on a CD or other electronically controlled device and is intended for healthcare professionals to remotely consult on patient status and review near real-time patient data, waveforms, and alarms to aid in clinical decisions.
The recall is being conducted due to a mismatch between the alarm priority on the medical devices and the Vital Sync system. This discrepancy could affect the timely delivery of patient care and clinical decision-making. The affected units are distributed in the United States to the states of Louisiana, Illinois, Mississippi, Colorado, Indiana, Georgia, California, and Texas.
Healthcare professionals using this software should contact Nellcor Puritan Bennett Inc. for instructions on how to correct the alarm priority mismatch. The specific model number is 10007101 and the lot number is 14A0041IN.
The recalled product
- 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…
- Manufacturer
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Category
- Medical Device — Software
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model # 10007101
- Lot # 14A0041IN
Distribution
Part of a larger recall action
This product is one of 2 recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Nellcor Puritan Bennett Inc. (dba Covidien LP)
See all →- SevereCovidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure
FDA (Devices) · 2014-12-17
- SevereFDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue
FDA (Devices) · 2014-11-05
- ModerateVital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch
FDA (Devices) · 2014-08-20
- HighPuritan Bennett 840 Ventilator Recall for Display Loss
FDA (Devices) · 2014-07-02
- HighNellcor Puritan Bennett PB840 Ventilator Display Component Recalled
FDA (Devices) · 2014-06-25
Similar recalls
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- ModerateMedtronic CareLink SmartSync Device Manager Recall for Inaccurate Longevity Estimates
FDA (Devices) · 2019-11-06
- ModerateMedtronic Recalls CareLink SmartSync Device Manager for Longevity Error
FDA (Devices) · 2021-05-12
- LowMedtronic CareLink Pro Software Recall for Inaccurate Basal Data Display
FDA (Devices) · 2015-03-11
- HighMedtronic Recalls CareLink SmartSync Device Manager Due to Software Error
FDA (Devices) · 2021-05-12
- HighNellcor bedside SpO2 monitor alarms may not be heard or recognized
FDA (Devices) · 2025-07-30