TANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide
FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.
- Product
- TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
- Category
- Medical Device
- Distribution
- Distributed nationwide