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FDA (Device enforcement)Recalled 2017-03-02closedclass ii

Philips Visicu: eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physio

Is my product affected?

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 intend

  • UPC 453564506091

Check against the official notice below — it lists the full affected range.

What happened

Philips is recalling the eCareCoordinator (eCC) software, which is used in hospitals and clinical settings to collect patient data from monitoring devices and ancillary systems, store that information, and transmit it to remote care teams. A software defect has been discovered in the Clinical User Interface that can sometimes cause patient data to be saved as missing or duplicated without alerting the user to the problem.

The recall affects 26 units of eCareCoordinator software (Lot/code 453564506091) distributed worldwide and across the United States. The recall notice does not specify a remedy for affected consumers or healthcare facilities.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: Worldwide Distribution-US Nationwide Quantity: 26 Lot/code info: 453564506091 eCareCoordinator

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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