Recall Z-0142-2014 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Sorin Group Deutschland GmbH
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.
| Date | Nov 4, 2013 (initiated Sep 24, 2013) |
| Status | Terminated |
| Reason | Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. |
| Root cause | Software Manufacturing/Software Deployment |
| 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. |
| Quantity | 84 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH, Jul 6, 2007 |