Z-2235-2014Class II

Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled...

Name: Z-2235-2014 Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled...
Creator: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Published: 2014-07-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-07-17 / Terminated / root cause: software

FDA source

Nellcor Puritan Bennett Inc. (dba Covidien LP) began a recall of 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... on 2014-07-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2235-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-17
Posted: 2014-08-14
Terminated: 2014-10-21
Recalling firm: Medtronic, Inc.
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.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Covidien, sent an "URGENT FIELD CORRECTIVE ACTION NOTICE" letter dated 7/16/14 to its customers on 7/17/14 via FedEx. The letter informs users that a representative will be in contact to schedule a software update.The letter also described the product, problem and actions to be taken. The customers were instructed to disregard the audible and visual alarm priority indicators and only use the alarm description text on the patient tile and on the patient detail page for alarm priority information, until the mismatch is corrected. The Vital Sync" Virtual Patient Monitoring Platform and Informatics Manager or Vital Sync" Remote Monitoring System may still be used until the software update is available. If you have questions about this letter or to report any issues with the Vital Sync" Virtual Patient Monitoring Platform and Informatics Manager or Vital Sync" Remote Monitoring System, contact our Technical Support Department at (800)635-5267, option 3, then option 1.
Quantity in commerce: 9
Distribution: US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
Product codes and lots: Model # 10116080 ; Lot # PO643063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2235-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2234-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2235-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14

Product code MWI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)