Devices

Device Recall Stockert S5 System I Sorin C5 System

Model / Serial
S5 Item Number: 10-80-00, 10-85-00, 28-9S-80, 28-95-8S. C5 Item Number: S8-00-00
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.
Product Description
S5/C5 Heart-lung machine || Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Manufacturer
Sorin Group Deutschland GmbH
1 Event
- Recall of Device Recall Stockert S5 System I Sorin C5 System

Manufacturer

Sorin Group Deutschland GmbH

Manufacturer Address
Sorin Group Deutschland GmbH, Lindberghstrasse 25, Munchen Germany
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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