Company:MVisicu, Inc., .
Date of Enforcement Report 5/16/12
Class ll:
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. Recall # Z-1474-2012
REASON
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.
RECALLING FIRM/MANUFACTURER
Visicu, Inc., Baltimore, MD, by letter dated February 22, 2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide
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