Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monito
FDA device recall Z-0883-2009 · posted 2009-01-28 · Terminated
Recall details
- Recalling firm
- Zoll Lifecor Corporation
- Reason for recall
- The charging circuit will not shut down properly.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MVK
- Quantity affected
- 1685 units
- Distribution
- Nationwide. OUS: Germany, United Kingdom, Italy, and France.
- Date initiated
- 2008-10-21
- Date posted
- 2009-01-28
- Date terminated
- 2009-11-04
- Location
- Pittsburgh, PA
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