TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Reported: October 5, 2022 Initiated: July 21, 2022 #Z-1763-2022
Product Description
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Reason for Recall
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
Details
- Recalling Firm
- Cardiac Assist, Inc
- Units Affected
- 723 units (484 currently in field)
- Distribution
- US Nationwide distribution.
- Location
- Pittsburgh, PA
Frequently Asked Questions
What product was recalled? ▼
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.. Recalled by Cardiac Assist, Inc. Units affected: 723 units (484 currently in field).
Why was this product recalled? ▼
Critical Failure of the LifeSPARC controller when 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 October 5, 2022. Severity: Critical. Recall number: Z-1763-2022.
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