FDA-Device2012-11-07Class II
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
Sorin Group USA, Inc.
Hazard
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.
Sold states
Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.
Affected count
12 units (3 units USA and 9 units OUS)
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0166-2013Don't want to check this manually?
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