FDA-Device2016-05-04Class II

eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

Philips Visicu
Hazard

The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. An error message is generated and forwarded to operations. Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. If the pa

Sold states
US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
Affected count
9
Manufactured in
217 E Redwood St Ste 1900, N/A, Baltimore, MD, United States
Products
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1557-2016

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