FDA Medical Device Recalls (openFDA)
Lifecor Inc: Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.
- Recall number
- Z-0578-03
- Recalling firm
- Lifecor Inc
- Product
- Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.
- Status
- Terminated
- Initiated
- 2003-01-10
- Posted
- 2003-02-26
- Terminated
- 2003-07-30
- Reason
- Wires may break or pull out, causing device to malfunction
- 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
- 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.
- Lot, serial or model codes
- Product No 10A0889-A01
- 510(k) numbers
- not on file
- PMA numbers
- ["P010030"]
- Product code
- not on file
- 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