Recall Z-1156-2012 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Sorin Group USA, Inc.
SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, S5 TWO MAST PUMPS 85 W/ COUPLING, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-62 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
| Date | Mar 5, 2012 (initiated Feb 16, 2012) |
| Status | Terminated |
| Reason | Touch screen may be unresponsive, inhibiting user input. |
| Root cause | 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 |
| Quantity | 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, Ku |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060053 | STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH, Jun 2, 2006 |