Z-0578-03

Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI

Name: Z-0578-03 Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI
Creator: Lifecor Inc
Published: 2003-01-10
License: https://open.fda.gov/license/

ZOLL Manufacturing Corporation / initiated 2003-01-10 / Terminated

FDA source

Lifecor Inc began a recall of Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI on 2003-01-10. The reason FDA records is "Wires may break or pull out, causing device to malfunction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0578-03
Status: Terminated
Initiated: 2003-01-10
Posted: 2003-02-26
Terminated: 2003-07-30
Recalling firm: ZOLL Manufacturing Corporation
Product: Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.
Reason for recall: Wires may break or pull out, causing device to malfunction
FDA root cause: Other
Action: The recalling firm telephone the end/prescribed users and distributors. Follow up letters were issued to those that received phone calls. The end/prescribed users'' physicians were also notified via letter.
Quantity in commerce: 174 units
Distribution: The device was shipped to distributors, hospitals, sales representatives. End users were prescribed by their physician. Distribution was to: CA, FL, GA, ID, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, UT and WA; and to Spain, Denmark, Italy, Turkey, Germany, United Kingdom, France and Belgium.
Product codes and lots: Product No 10A0889-A01

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)