Z-0883-2009

Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within...

Name: Z-0883-2009 Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within...
Creator: Zoll Lifecor Corporation
Published: 2008-10-21
License: https://open.fda.gov/license/

ZOLL Manufacturing Corporation / initiated 2008-10-21 / Terminated / root cause: design

FDA source

Zoll Lifecor Corporation began a recall of Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult... on 2008-10-21. The reason FDA records is "The charging circuit will not shut down properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0883-2009
Status: Terminated
Initiated: 2008-10-21
Posted: 2009-01-28
Terminated: 2009-11-04
Recalling firm: ZOLL Manufacturing 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.
Product code: MVK Wearable Automated External Defibrillator
Reason for recall: The charging circuit will not shut down properly.
Root cause tag: design
FDA 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 in commerce: 1685 units
Distribution: Nationwide. OUS: Germany, United Kingdom, Italy, and France.
Product codes and lots: model numbers WCD3000 and WCD3100

Product code MVK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)