FDA Medical Device Recalls (openFDA)
Sorin Group Deutschland GmbH: S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
- Recall number
- Z-0142-2014
- Recalling firm
- Sorin Group Deutschland GmbH
- Product
- S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
- Status
- Terminated
- Initiated
- 2013-09-24
- Posted
- 2013-11-04
- Terminated
- 2014-07-10
- Reason
- Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801
- 510(k) numbers
- ["K071318"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 3002808267
- Firm city
- Munchen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28