Liebel-Flarsheim Co Class II

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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.