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

FDA device recall Z-2235-2014 · posted 2014-08-14 · Terminated

Recall details

Recalling firm

Nellcor Puritan Bennett Inc. (dba Covidien LP)

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

MWI

Quantity affected

9

Distribution

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

Date initiated

2014-07-17

Date posted

2014-08-14

Date terminated

2014-10-21

Location

Boulder, CO

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