Device 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.
Z-0142-2014
Product summary
- Event
- Event 66464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84
- Official record key
device-enforcement:Z-0142-2014
Official wording
Reason: Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Unknown
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.