Reported Dec 16, 2015 · Terminated

The eCareManager system. Software intended for use in data collection, storage and clinical information management with…

Visicu, Inc.

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: Visicu, Inc. · 217 E Redwood St Ste 1900 · Baltimore, MD · 21202-3315

Is this the product you have?

  • The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
Lot codes and dates
    • eCareManager v3.7
    • 3.7.1
    • v3.8
    • and v3.9
Amount recalled
43

Why it was recalled

A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.

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 Sep 23, 2016 · Data as of Sep 19, 5:19 PM UTC

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