Company: Philips Visicu
Date of Enforcement Report 5/4/2016
Class lI:
PRODUCT
IeCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff. Recall Number Z-1557-2016
REASON
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. .
RECALLING FIRM/MANUFACTURER
Philips Visicu, Baltimore, MD on 3/10/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9
DISTRIBUTION
FL, MA, MI, MS, PA, and KS.
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