S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 8
FDA device recall Z-1153-2012 · posted 2012-03-05 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Touch screen may be unresponsive, inhibiting user input.
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 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
- Date initiated
- 2012-02-16
- Date posted
- 2012-03-05
- Date terminated
- 2012-11-09
- Location
- Arvada, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STOCKERT S5 SYSTEM (K060053) | Sorin Group Deutschland GmbH | 2006-06-02 |