Z-1708-2017 Class II Terminated

Recalled by Philips Visicu — Baltimore, MD

Recall Details

Product Type
Devices
Report Date
April 12, 2017
Initiation Date
March 2, 2017
Termination Date
October 27, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution-US Nationwide

Code Information

453564506091 eCareCoordinator