| Subject: | Class 1 Recall - Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) |
| Category: | Food and Drug Administration (FDA)
|
| Published: | Tue, 5 Aug 2008 - 10:00 am |
| Levitronix and FDA notified healthcare professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2008. The Blood Pumping System is used to provide short-term extracorporeal circulatory support during cardiac and other types of surgeries. A July 24, 2008 Levitronix device correction letter informed physicians not to use... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
|
RESOURCES:
External Links:
|
|
StayAlert! provides immediate notification of regulatory body legislation impacting the healthcare industry, helping you to meet regulatory compliance. Subscribers are notified of any new or revised regulations, provided with a summary of the regulation, followed by an implementation action plan and/or policy. Designed as an e-mail "push" method for rapid customer notification of healthcare compliance issues, paired with interpretative analysis and practical application, the StayAlert!® Virtual Compliance Administrator™ saves you time and money. Currently StayAlert! is the leader in the comprehensive compliance information marketplace. Why? Because StayAlert! provides healthcare professionals with more than information. StayAlert! provides a service, in many cases "doing the work" for you, and assisting regulatory compliance officers to effectively and efficiently meet changing standards. |
|