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U.S. Department of Health and Human Services

Class 2 Device Recall eCare Coordinator

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  Class 2 Device Recall eCare Coordinator see related information
Date Initiated by Firm March 02, 2017
Create Date April 04, 2017
Recall Status1 Terminated 3 on October 27, 2017
Recall Number Z-1708-2017
Recall Event ID 76660
510(K)Number K141706  
Product Classification Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
Product eCare Coordinator

Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
Code Information 453564506091  eCareCoordinator 
Recalling Firm/
Manufacturer		 Philips Visicu
217 E Redwood St Ste 1900
Baltimore MD 21202-3315
Manufacturer Reason
for Recall		 eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action Field Safety Notice (FSN) will be sent to all customers using eCareCoordinator all Versions. The FSN describes the problem and circumstances in which the design defects occurs and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. A software correction will be made and released.by the vendor. Customers will have this correction applied to their current version when made available by Vendor in order to fix this correction.
Quantity in Commerce 26
Distribution Worldwide Distribution-US Nationwide
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 = DRG and Original Applicant = VISICU, INC.
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