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.
Reported: January 25, 2023 Initiated: December 5, 2022 #Z-0926-2023
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Cardiac Assist, Inc
- Units Affected
- 763 (US only)
- Distribution
- US Nationwide distribution.
- Location
- Pittsburgh, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cardiac Assist, Inc. Units affected: 763 (US only).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2023. Severity: Critical. Recall number: Z-0926-2023.
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