Recall Z-0399-2016 ยท MSX System, Network And Communication, Physiological Monitors
Visicu, Inc.
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 h
| Date | Dec 10, 2015 (initiated Mar 27, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root 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 u |
| Quantity | 43 |
| Distribution | US distribution only. |
| FDA record | Open on fda.gov |