FDA-Device2023-01-25Class I
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
Cardiac Assist, Inc
Hazard
A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.
Sold states
US Nationwide distribution.
Affected count
763 (US only)
Manufactured in
240 Alpha Dr, N/A, Pittsburgh, PA, United States
Products
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0926-2023Don't want to check this manually?
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