Philips Visicu recalls eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). Fo…

Recall date

March 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1557-2016

FDA classification

Class II

Brand / firm

Philips Visicu

Sold / distributed

US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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