Company: Cardiac Assist, Inc
Date of Enforcement Report: 9/23/2022
Class I
PRODUCT
Devices
Recall Number:
Z-1763-2022
REASON
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
RECALLING FIRM/MANUFACTURER
Cardiac Assist, Inc
VOLUME OF PRODUCT IN COMMERCE
723 units (484 currently in field)
DISTRIBUTION
US Nationwide distribution.
