FDA-Device2022-10-05Class I
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Cardiac Assist, Inc
Hazard
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
Sold states
US Nationwide distribution.
Affected count
723 units (484 currently in field)
Manufactured in
240 Alpha Dr, N/A, Pittsburgh, PA, United States
Products
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1763-2022Don't want to check this manually?
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