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Recall Observatory FDA recall evidence

Device product

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.

Z-0166-2013

September 20, 2012

Class II

Product summary

Firm
Sorin Group USA, Inc.
Event
Event 63381
Status
Terminated
Classification
Class II
Quantity
12 units (3 units USA and 9 units OUS)
Official record key
device-enforcement:Z-0166-2013

Official wording

Reason: 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.

Code information: Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.

Distribution pattern: Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification