S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
FDA Recall Z-0142-2014 · Posted 2013-11-04
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Recalling FirmSorin Group Deutschland GmbH
Recall StatusTerminated
Product CodeDTQ
Date Initiated2013-09-24
Date Terminated2014-07-10
Product Quantity84
Reason for Recall
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Firm Action
Sorin Group sent an Urgent Field Safety Notice dated September 24, 2013, to all affected customers. The letter informed users of the potential for failing of automatic cardioplegia delivery function and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to update the firmware on site. Customers were asked to complete the Response form to confirm they had received, read and understood the Field Notice. For questions regarding this recall call 303-467-6527.
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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