Philips Visicu recalls eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, st…

Recall date

March 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1708-2017

FDA classification

Class II

Brand / firm

Philips Visicu

Sold / distributed

Worldwide Distribution-US Nationwide

Why it was recalled

eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.