28
Sep
2016

Philips Expression Information Portal Cl II

,
0

Company:Invivo Corporation
Date of Enforcement Report 9/28/2016
Class lI:

PRODUCT

Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps..
Recall Number Z-2790-2016

REASON
Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.

RECALLING FIRM/MANUFACTURER
Invivo Corporation, Orlando, FL on 9/21/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
639 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

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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