Devices

Device Recall C5 Mobile Console

Model / Serial
Item number: 58-00-00 Serial numbers 58E00023 to 58E20030.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
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
Product Description
SORIN C5 CONSOLE Part No.: 58-00-00, 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.
Manufacturer
Sorin Group USA, Inc.
1 Event
- Recall of Device Recall C5 Mobile Console

Manufacturer

Sorin Group USA, Inc.

Manufacturer Address
Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA

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