notyard
04-14-2009, 02:52 PM
FDA class II recall:
PRODUCT
Monitor portion of the LifeVest device – specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Model numbers: WCD3000 and WCD3100. Recall # Z-0883-2009
CODE
Unknown
RECALLING FIRM/MANUFACTURER
Zoll Lifecor Corp., Pittsburgh, PA, by letter dated October 21, 2008. Firm initiated recall is ongoing.
REASON
The charging circuit will not shut down properly.
VOLUME OF PRODUCT IN COMMERCE
1,685 units
DISTRIBUTION
Nationwide, Germany, United Kingdom, Italy and France
PRODUCT
Monitor portion of the LifeVest device – specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Model numbers: WCD3000 and WCD3100. Recall # Z-0883-2009
CODE
Unknown
RECALLING FIRM/MANUFACTURER
Zoll Lifecor Corp., Pittsburgh, PA, by letter dated October 21, 2008. Firm initiated recall is ongoing.
REASON
The charging circuit will not shut down properly.
VOLUME OF PRODUCT IN COMMERCE
1,685 units
DISTRIBUTION
Nationwide, Germany, United Kingdom, Italy and France