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FDAMarch 10, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Terminated

Brands named

philips visicuphilips

UPCs

453564506091

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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