The Recall Desk
HighFDA (Devices)·Z-2234-2014·Announced 2014-08-20

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.

What this means for you

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 fo
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

Distributed in 8 states:

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)

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