Class 2 Device Recall eCareManager

• Date Initiated by Firm: March 27, 2015
• Date Posted: December 10, 2015
• Recall Status: Terminated on September 23, 2016
• Recall Number: Z-0399-2016
• Recall Event ID: 70931
• 510(K)Number: K001972 K012171
• Product Classification: System,network and communication,physiological monitors - Product Code MSX
• Product: The eCareManager system. Software 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. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
• Code Information: eCareManager v3.7, 3.7.1, v3.8, and v3.9
• Recalling Firm/ Manufacturer: Visicu, Inc.; 217 E Redwood St Ste 1900; Baltimore MD 21202-3315
• Manufacturer Reason for Recall: A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.
• FDA Determined Cause: Software design
• Action: Philips Visicu sent an "Field Safety Notification" to all affected customers still using an affected version of eCareManager. (4 Customers) 03/27/2015 The letter identified the problem and circumstances in which the defect can occur; recommend actions the customer should take to prevent risks for patients; and list the actions planned by Philips to correct the problem. "Philips Hospital to Home has taken corrective action to address the software defect in all supported versions of eCareManager software. Philips Hospital to Home is working with affected customers to complete the necessary upgrade. Please contact your local Philips Representative for further questions.
• Quantity in Commerce: 43
• Distribution: US distribution only.
• 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