FDA Medical Device Recalls (openFDA)
Sorin Group USA, Inc.: S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
- Recall number
- Z-1153-2012
- Recalling firm
- Sorin Group USA, Inc.
- Product
- S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
- Status
- Terminated
- Initiated
- 2012-02-16
- Posted
- 2012-03-05
- Terminated
- 2012-11-09
- Reason
- Touch screen may be unresponsive, inhibiting user input.
- Root cause
- Mixed-up of materials/components
- Action
- All affected US customers and distributors were notified of the Sorin S5 HLM Touch Screen Field Correction by certified mail on 02/15/12. The letter informed users of the potential for unresponsive S5 HLM touch screens and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to replace affected touch screens on site. Customers and distributors were also provided with a Response Form to confirm they had received, read and understood the Field Correction Notice. They were instructed to fax the completed form to (303) 467-6502. For questions regarding this recall call 303-467-6306.
- Quantity
- 2 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Bulgaria, China, Denmark, Germany, Ecuador, Egypt, Finland, France, Georgia, Greece, United Kingdom, Hong Kong, Indonesia, Iraq, Iran, Israel, Italy, Japan, Jordan, Canada, British Columbia, South Korea, Kuwait, La Reunion, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Morocco, Mexico, Monaco, New Zealand, Netherlands, Norway, Oman, Austria, Phillippines, Poland, Portugal, Puerto Rico, Qatar, Serbia, Russia, Saudi Arabia, Sweden, Switzerland, Singapore, Spain, South Africa, Syria, Thailand, Czechoslavakia, Tunisia, Turkey, Hungary, Vietnam, and the United Arab Ermirates
- Lot, serial or model codes
- Item number: 28-95-85; Serial numbers 50E65207 to 50E65212.
- 510(k) numbers
- ["K060053"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- Firm country
- not on file
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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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