FDA Medical Device Recalls (openFDA)
Nellcor Puritan Bennett Inc. (dba Covidien LP): 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 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.
- Recall number
- Z-2234-2014
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- 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 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.
- Status
- Terminated
- Initiated
- 2014-07-17
- Posted
- 2014-08-14
- Terminated
- 2014-10-21
- Reason
- 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
- 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
- 3
- Distribution
- US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
- Lot, serial or model codes
- Model # 10007101; Lot # 14A0041IN
- 510(k) numbers
- ["K130796","K132604","K140339"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 2936999
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28