# K071318: Modification to: Stockert S5 System

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jul 6, 2007 after 57 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971520 (1997). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062396: Modification to Stockert S5 System, Sorin Group Deutschland GmbH (2006) Summary page 1.
- K950990: Stockert S3 Roller Pump Module Stockert S3 Console, Stoeckert Instrumente (1996) Summary page 1.
- K042374: Stockert SCP Rhythm, Stockert Instrumente GmbH (2004) Summary page 1.
- K971520: S3 Cyclic RPM Control, Stoeckert Instrumente (1997) Summary page 1.

## Most influential descendants
- K210130: Stockert S5 System (2021), 2 descendants of its own
- K112225: Sorin Centrifugal Pump 5 (CP5) (2011), 2 descendants of its own
- K082344: Stockert S5 System, Stockert Electrical Venous Occluder (Evo) (2008), 2 descendants of its own
- K221373: Essenz HLM (2023), 1 descendant of its own
- K232291: Essenz HLM, Essenz ILBM (2023), 0 descendants of its own

## Recalls of this device
- Jan 28, 2019 · Class III · Z-1119-2020: 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
- Aug 25, 2016 · Class II · Z-2866-2016: Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.
- Dec 4, 2013 · Class II · Z-0856-2014: 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.
- Sep 24, 2013 · Class II · Z-0142-2014: Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
- Sep 19, 2012 · Class II · Z-0274-2013: 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 dis
- Sep 19, 2012 · Class II · Z-0275-2013: 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 dis
- Sep 19, 2012 · Class II · Z-0272-2013: 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 dis
- Sep 19, 2012 · Class II · Z-0271-2013: 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 dis
- Sep 19, 2012 · Class II · Z-0273-2013: 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 dis
- Feb 23, 2012 · Not classified · Z-1326-2012: 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 t
- Feb 23, 2012 · Not classified · Z-1328-2012: 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 t
- Feb 23, 2012 · Not classified · Z-1327-2012: 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 t
- Feb 23, 2012 · Not classified · Z-1325-2012: 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 t

## Indications for use
The modified S5 and the Pulse Mode Control for the SCP/S5 are used with the SCP Rhythm System in conjunction with the Stöckert S5 System during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Source page: https://510kreport.com/device/K071318
Methodology: https://510kreport.com/methodology