Events

Recall of Device Recall Stockert S5 System I Sorin C5 System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group Deutschland GmbH.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67199
  • Event Risk Class
    Class 2
  • Event Number
    Z-0856-2014
  • Event Initiated Date
    2013-12-04
  • Event Date Posted
    2014-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124941
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Reason
    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.
  • Action
    Sarin Group US distributed a Field Safety Notice dated December 5, 2013 to all affected customers and distributors. The letter informed users of the potential for shaft encoder failures and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to repair the units onsite. Customers and distributors were also provided with a Response form to confirm they had received, read and understood the Field Notice. They were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For questions call 303-467-6527 or 303-467-6503.

Device

Device Recall Stockert S5 System I Sorin C5 System
  • Model / Serial
    S5 Item Number: 10-80-00, 10-85-00, 28-9S-80, 28-95-8S. C5 Item Number: S8-00-00
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.
  • Product Description
    S5/C5 Heart-lung machine || Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
  • Manufacturer
    Sorin Group Deutschland GmbH

Manufacturer

Sorin Group Deutschland GmbH
  • Manufacturer Address
    Sorin Group Deutschland GmbH, Lindberghstrasse 25, Munchen Germany
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA