Reported Apr 12, 2017 · Terminated

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

Philips Visicu

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Visicu · 217 E Redwood St Ste 1900 · Baltimore, MD · 21202-3315

Is this the product you have?

  • eCare Coordinator Product Usageis 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
Lot codes and dates
  • 453564506091 eCareCoordinator
Amount recalled
26

Where it was sold

  • 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 27, 2017 · Data as of Sep 19, 6:06 PM UTC

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