29
May
2002

Liebel-Flarsheim Co Class II

0

Company: Liebel-Flarsheim Co
Date of Enforcement Report: 5/29/2002
Class: II

PRODUCT
Liebel-Flarsheim Angiomat Illumena Media Power Injectors, P/N 900001, using Version 8.0 software with new console.
Recall # Z-1046-2.

REASON
Pushing the scoll button repeatedly / rapidly results in erroneous protocol ID.

CODE
Serial Numbers: 0202-5000 to 0402-5126.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt, Inc. / Liebel-Flarsheim Business, Cincinnati, OH, by telephone beginning April 22 and by letter on April 23, 2002.
Manufacturer: Liebel-Flarsheim Co., Cincinnati, OH. Firm initiated
recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
62.

DISTRIBUTION
Nationwide and Canada, Taiwan, China, So. Africa and Australia.

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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