Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Vital Sync RMS 1.0 when loaded with v2.4 software Recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) Due to Covidien is conducting a field correction of the...

Date: July 17, 2014
Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nellcor Puritan Bennett Inc. (dba Covidien LP) directly.

Affected Products

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.

Quantity: 9

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 8 states: CA, CO, GA, IL, IN, LA, MS, TX

Affected (8 states)Not affected

About Nellcor Puritan Bennett Inc. (dba Covidien LP)

Nellcor Puritan Bennett Inc. (dba Covidien LP) has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report