Cardiac Science Corp. (CSCX), a small maker of emergency defibrillators, said Wednesday it's launching a worldwide voluntary recall after determining about 12,200 devices could fail and threaten lives by not delivering therapy.
The Bothell, Wash., company, which advised customers in November to watch for a separate problem with some of the same devices, said it found the new issue itself. It has not received complaints or reports of problems, and has reported the matter to the Food and Drug Administration.
Cardiac Science expects to record a $2 million to $3 million fourth-quarter charge reflecting its current estimate of costs linked to the recall.
"The company does not currently believe this action will have a significant adverse impact on its ability to fulfill AED orders for the first quarter," it said in a release. The products at issue--automated external defibrillators--are known as AEDs.
Cardiac Science shares slipped to $2.69 in after-hours trading from Wednesday's close of $2.77 following an 8-cent gain during regular trading hours.
The latest problem involves certain AEDs made between Oct. 19 and Jan. 15. The specific models are the Powerheart 9300A, 9300E, 9300P, 9390A and 9390E; the CardioVive 92532; and the CardioLife 9200G and 9231.
Source : http://online.wsj.com/article/BT-CO-20100203-717724.html?mod=WSJ_latestheadlines
The Bothell, Wash., company, which advised customers in November to watch for a separate problem with some of the same devices, said it found the new issue itself. It has not received complaints or reports of problems, and has reported the matter to the Food and Drug Administration.
Cardiac Science expects to record a $2 million to $3 million fourth-quarter charge reflecting its current estimate of costs linked to the recall.
"The company does not currently believe this action will have a significant adverse impact on its ability to fulfill AED orders for the first quarter," it said in a release. The products at issue--automated external defibrillators--are known as AEDs.
Cardiac Science shares slipped to $2.69 in after-hours trading from Wednesday's close of $2.77 following an 8-cent gain during regular trading hours.
The latest problem involves certain AEDs made between Oct. 19 and Jan. 15. The specific models are the Powerheart 9300A, 9300E, 9300P, 9390A and 9390E; the CardioVive 92532; and the CardioLife 9200G and 9231.
Source : http://online.wsj.com/article/BT-CO-20100203-717724.html?mod=WSJ_latestheadlines
No comments:
Post a Comment