Nellcor Puritan Bennett Inc. (dba Covidien LP): Medical Device Recall in 2014 - (Recall #: Z-2235-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 17, 2014

Date Posted: August 20, 2014

Recall Number: Z-2235-2014

Event ID: 68802

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.

Status: Terminated

Product Quantity: 9

Code Information:

Model # 10116080 ; Lot # PO643063

Distribution Pattern:

US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated