Philips Expression Information Portal Cl II

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

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.