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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm July 17, 2014
Date Posted August 14, 2014
Recall Status1 Terminated 3 on October 21, 2014
Recall Number Z-2235-2014
Recall Event ID 68802
510(K)Number K130796  K132604  K140339  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
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.
Code Information Model # 10116080 ; Lot # PO643063
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett Inc. (dba Covidien LP)
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact Mr. Michael A. Ronningen
303-530-6100
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = COVIDIEN
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