FDAMarch 2, 2017device

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 int...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

philips visicuphilips

UPCs

453564506091

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 int... — Recall Details · AllClear