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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 10, 2016
Create Date April 22, 2016
Recall Status1 Terminated 3 on October 27, 2017
Recall Number Z-1557-2016
Recall Event ID 73673
510(K)Number K141706  
Product Classification Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
Product eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure).

For medical use by professional medical staff.
Code Information 453564506091 eCareCoordinator 1.3
Recalling Firm/
Manufacturer		 Philips Visicu
217 E Redwood St Ste 1900
Baltimore MD 21202-3315
Manufacturer Reason
for Recall		 The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. An error message is generated and forwarded to operations. Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. If the pa
FDA Determined
Cause 2		 Under Investigation by firm
Action 1. Field Safety Notice(FSN) will be sent to all customers using eCareCoordinator v.1.3 platform. The FSN describes the problem and the circumstances in which the design defects occur and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. 2. A software correction will be made and released. Customers will be upgraded to eCC v.1.4. The v.1.4 is scheduled to be released on or about 8 March 2016. The defect will have been corrected and tested.
Quantity in Commerce 9
Distribution US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
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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