Cl II Philips Visicu eCareCoordinator

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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