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U.S. Department of Health and Human Services

Class 2 Device Recall Philips eCareManager System

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  Class 2 Device Recall Philips eCareManager System see related information
Date Initiated by Firm February 22, 2012
Date Posted April 27, 2012
Recall Status1 Terminated 3 on July 06, 2012
Recall Number Z-1474-2012
Recall Event ID 61328
510(K)Number K001972  K012171  
Product Classification System,network and communication,physiological monitors - Product Code MSX
Product Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8.

Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.
Code Information v3.7, v3.7.1, v3.8
Recalling Firm/
Manufacturer		 Visicu, Inc.
217 E Redwood St Ste 1900
Baltimore MD 21202-3315
For Additional Information Contact Ken Sterner
410-276-1960
Manufacturer Reason
for Recall		 Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.
FDA Determined
Cause 2		 Software change control
Action Philips notified all affected customers via a preliminary email message advising them of the issue. An URGENT - Field Safety Notice follow-up letter was mailed to all customers on February 22, 2012. This letter identified the affected product, described the problem and circumstances in which it can occur; recommend actions the customer should take to prevent risks for patients, and list the actions planned by Philips to correct the problem. For questions contact Philips eICU Customer Support 877-374-2872.
Quantity in Commerce 12
Distribution Nationwide Distribution (USA) including states of MA, MO, WI, AR, AZ, PA, SD, VA, and IN.
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 = MSX and Original Applicant = VISICU, INC.
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