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

Recalled April 12, 2017 · FDA recall Z-1708-2017 · Philips Visicu

Hazard
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. · FDA Class II
Units
26
Sold at
Worldwide Distribution-US Nationwide

Description

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.

Product
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.
Manufacturer(s)
Philips Visicu

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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