S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary b
FDA device recall Z-0856-2014 · posted 2014-01-28 · Terminated
Recall details
- Recalling firm
- Sorin Group Deutschland GmbH
- 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.
- Action taken
- 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. For questions call 303-467-6527 or 303-467-6503.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 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,
- Date initiated
- 2013-12-04
- Date posted
- 2014-01-28
- Date terminated
- 2015-12-28
- Location
- Munchen, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SORIN C5 SYSTEM MODEL 58-00-00 (K093882) | Sorin Group Deutschland GmbH | 2010-01-15 |
| MODIFICATION TO: STOCKERT S5 SYSTEM (K071318) | Sorin Group Deutschland GmbH | 2007-07-06 |