30
May
2001

Inc. Class II Cardiomedics

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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