Stockert S5 Manual
Class 2 Device Recall Stockert S5 System I Sorin C5 System Date Initiated by Firm December 04, 2013 Date Posted January 28, 2014 Recall Status Terminated on December 28, 2015 Recall Number Z-0856-2014 Recall Event ID 510(K)Number Product Classification - Product Code Product 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. Code Information S5 Item Number: 10-80-00, 10-85-00, 28-9S-80, 28-95-8S. C5 Item Number: S8-00-00 Recalling Firm/ Manufacturer Sorin Group Deutschland GmbH Lindberghstrasse 25 Munchen Germany For Additional Information Contact Amritt Khorran 303-467-6306 Manufacturer Reason for Recall 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.
FDA Determined Cause Device Design 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.
DESCRIPTION A quantum leap in perfusion technology. For the perfusionist who demands intelligent, functional ergonomics and reliable safety systems, the S5™ delivers its refined modular design permits the quick and easy exchanging of individual components in even the most challenging of environments. The S5 was designed to meet the diverse needs of today's hospital—and then keep pace with you as your needs change. SIII and SIII Encore™ system users can transfer their external devices such as data management system or SCP to the new S5 System.
For questions call 303-467-6527 or 303-467-6503. Quantity in Commerce 323 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.
Total Product Life Cycle 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see. 510(K) Database.
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Stockert S5 Manual
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