Modification to: Stockert S5 System

• • Terminated Z-1119-2020 FDA Class III ·initiated 28 Jan 2019

  Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.

• • Terminated Z-2866-2016 FDA Class II ·initiated 25 Aug 2016

  Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.

• • Terminated Z-0856-2014 FDA Class II ·initiated 4 Dec 2013

  Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.

• • Terminated Z-0142-2014 FDA Class II ·initiated 24 Sep 2013

  Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

• 4 recalls, same reason

  • Terminated Z-0274-2013 FDA Class II ·initiated 19 Sep 2012
  • Terminated Z-0275-2013 FDA Class II ·initiated 19 Sep 2012
  • Terminated Z-0272-2013 FDA Class II ·initiated 19 Sep 2012
  • Terminated Z-0273-2013 FDA Class II ·initiated 19 Sep 2012

  Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin

• • Terminated Z-0271-2013 FDA Class II ·initiated 19 Sep 2012

  Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determi

• 4 recalls, same reason

  • Terminated Z-1325-2012 FDA Not yet classified ·initiated 23 Feb 2012
  • Terminated Z-1327-2012 FDA Not yet classified ·initiated 23 Feb 2012
  • Terminated Z-1328-2012 FDA Not yet classified ·initiated 23 Feb 2012
  • Terminated Z-1326-2012 FDA Not yet classified ·initiated 23 Feb 2012

  The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft.

510(k) Number

K071318 ↗

FDA Product Code

DTQ

Device Class

Class II

Regulation

21 CFR Part 870.4220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Stockert S5 System

  Class II

  FDA 510(k) K062396 Active Cleared 28 Sep 2006

• Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X Rp 150 and Control Panel with Connecting Cables); S5/C5 Mast Rolle

  Class II

  FDA 510(k) K103762 Active Cleared 20 Jan 2011

• Air Purge Control System for S5 System Model 23-45-05

  Class II

  FDA 510(k) K091007 Active Cleared 2 Jul 2009

• Xtra

  Class II

  FDA 510(k) K131553 Active Cleared 21 Mar 2014

• Sorin Connect

  Class II

  FDA 510(k) K170460 Active Cleared 8 Jun 2017

• Sorin Flextherm

  Class II

  FDA 510(k) K140012 Active Cleared 31 Jan 2014

See all devices from Sorin Group Deutschland GmbH →