| Class 2 Device Recall S5 Control Panel | |
Date Initiated by Firm | February 16, 2012 |
Date Posted | March 05, 2012 |
Recall Status1 |
Terminated 3 on November 09, 2012 |
Recall Number | Z-1153-2012 |
Recall Event ID |
61208 |
510(K)Number | K060053 |
Product Classification |
Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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Product | S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA
The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. |
Code Information |
Item number: 28-95-85; Serial numbers 50E65207 to 50E65212. |
Recalling Firm/ Manufacturer |
Sorin Group USA, Inc. 14401 W 65th Way Arvada CO 80004
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For Additional Information Contact | 303-467-6306 |
Manufacturer Reason for Recall | Touch screen may be unresponsive, inhibiting user input. |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | All affected US customers and distributors were notified of the Sorin S5 HLM Touch Screen Field Correction by certified mail on 02/15/12. The letter informed users of the potential for unresponsive S5 HLM touch screens and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to replace affected touch screens on site.
Customers and distributors were also provided with a Response Form to confirm they had received, read and understood the Field Correction Notice. They were instructed to fax the completed form to (303) 467-6502.
For questions regarding this recall call 303-467-6306. |
Quantity in Commerce | 2 units |
Distribution | Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Bulgaria, China, Denmark, Germany, Ecuador, Egypt, Finland, France, Georgia, Greece, United Kingdom, Hong Kong, Indonesia, Iraq, Iran, Israel, Italy, Japan, Jordan, Canada, British Columbia, South Korea, Kuwait, La Reunion, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Morocco, Mexico, Monaco, New Zealand, Netherlands, Norway, Oman, Austria, Phillippines, Poland, Portugal, Puerto Rico, Qatar, Serbia, Russia, Saudi Arabia, Sweden, Switzerland, Singapore, Spain, South Africa, Syria, Thailand, Czechoslavakia, Tunisia, Turkey, Hungary, Vietnam, and the United Arab Ermirates |
Total Product Life Cycle | TPLC Device Report |
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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 medical device recalls. 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 Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DTQ
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