Recall Z-1763-2022— Cardiac Assist, Inc
Class I · Terminated
Class I FDA medical device recall by Cardiac Assist, Inc, initiated 2022-07-21, terminated 2023-08-08. It names one FDA 510(k) clearance: K183623. Product: TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.. Reason: Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data..
- Recalling firm
- Cardiac Assist, Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2022-07-21
- Terminated
- 2023-08-08
- Firm location
- Pittsburgh, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.