FDA Medical Device Recalls (openFDA)
Zoll Lifecor Corporation: 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.
- Recall number
- Z-0883-2009
- Recalling firm
- Zoll Lifecor Corporation
- 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.
- Status
- Terminated
- Initiated
- 2008-10-21
- Posted
- 2009-01-28
- Terminated
- 2009-11-04
- Reason
- The charging circuit will not shut down properly.
- Root cause
- Component design/selection
- Action
- 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.
- Quantity
- 1685 units
- Distribution
- Nationwide. OUS: Germany, United Kingdom, Italy, and France.
- Lot, serial or model codes
- model numbers WCD3000 and WCD3100
- 510(k) numbers
- not on file
- PMA numbers
- ["P010030"]
- Product code
- MVK
- Firm FEI
- 3008642652
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28