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.
This recall has been terminated (originally issued January 28, 2009).
- Company
- Zoll Lifecor Corporation
- Recall Initiated
- October 21, 2008
- Posted
- January 28, 2009
- Terminated
- November 4, 2009
- Recall Number
- Z-0883-2009
- Quantity
- 1685 units
- Firm Location
- Pittsburgh, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The charging circuit will not shut down properly.
Distribution
Nationwide. OUS: Germany, United Kingdom, Italy, and France.
Lot / Code Info
model numbers WCD3000 and WCD3100
Root Cause
Component design/selection
Action Taken
Physicians with active patients were notified of the product removal by letter via first-class mail dated 10/21/2008. The letter describes the problem and the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267.