S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used d
FDA device recall Z-0142-2014 · posted 2013-11-04 · Terminated
Recall details
- Recalling firm
- Sorin Group Deutschland GmbH
- Reason for recall
- Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
- Action taken
- Sorin Group sent an Urgent Field Safety Notice dated September 24, 2013, to all affected customers. The letter informed users of the potential for failing of automatic cardioplegia delivery function and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to update the firmware on site. Customers were asked to complete the Response form to confirm they had received, read and understood the Field Notice. For questions regarding this recall call 303-467-6527.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 84
- Distribution
- Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.
- Date initiated
- 2013-09-24
- Date posted
- 2013-11-04
- Date terminated
- 2014-07-10
- Location
- Munchen, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: STOCKERT S5 SYSTEM (K071318) | Sorin Group Deutschland GmbH | 2007-07-06 |