B. Braun (BIS) VenaTech LP Vena Cava Filter System
Reason: Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.
full text>> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=65749
Toshiba Digital Radiography System with Flat Panel Detector
Reason: System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.
full text>> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=65789
Monday, December 3, 2007
Recap: October / November 2007 Product Recalls
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