SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distributed by: Sorin Group USA, Inc.
FDA device recall Z-0965-2011 · posted 2011-01-26 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Touch screen may become unresponsive, inhibiting user input.
- Action taken
- All affected US customers and distributors were notified by certified mail on Nov 12, 2010 via a Field Correction letter. They were told that they would be contacted by Sorin to arrange an appointment to inspect and replace affected touch screens on site. They were told that they could safely continue using their S5 systems in accordance with the Operator's Manual and previously supplied instructions until the inspection and necessary replacement had been completed. A customer response form was also included for completion and return to the firm. Customers can contact the firm if they have any questions.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 79 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2010-11-12
- Date posted
- 2011-01-26
- Date terminated
- 2012-07-13
- Location
- Arvada, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STOCKERT S5 SYSTEM (K060053) | Sorin Group Deutschland GmbH | 2006-06-02 |