Company: Cardiomedics, Inc.
Date of Enforcement Report: 5/30/01
Class: II
PRODUCT:
CardiAssist External Counter Pulsation (ECP)System. Recall #Z-573-1.
REASON:
The screen on the unit containing software version 1.4.3 intermittently locks
up. Unexpected shutdown; deletion of use for cardiogenic shock.
CODES:
n/a
MANUFACTURER:
Cardiomedics, Inc., Irvine, CA.
RECALLED BY:
Manufacturer, by facsimile, dated April 4, 2001, and representatives will make
field corrections. Firm-initiated recall completed.
DISTRIBUTION:
Nationwide and Israel.
QUANTITY:
36
