FDA Medical Device Recalls (openFDA)
GMP Companies/Lifesync Corporation: LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
- Recall number
- Z-0546-2007
- Recalling firm
- GMP Companies/Lifesync Corporation
- Product
- LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
- Status
- Terminated
- Initiated
- 2007-01-10
- Posted
- 2007-02-27
- Terminated
- 2009-07-27
- Reason
- When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.
- Root cause
- Other
- Action
- The recall was initiated on January 15, 2007. The firm''s representatives, hand carried, Device Recall Letter to Account Representative and Risk Manager. Distributors who received the Device Recall Letter, purged their stock of the affected devices and notified their customers. Recall Communication was hand carried to each account with 100% compliance by LifeSync Clinical/Sales Personnel. EFFECTIVENESS CHECKS of this recall will be achieved through Return Material Authorization via telephone with each affected account.
- Quantity
- 272 cases
- Distribution
- Nationwide
- Lot, serial or model codes
- C6310, C6324 and C6297.
- 510(k) numbers
- ["K030795"]
- PMA numbers
- not on file
- Product code
- DRG
- Firm FEI
- 1000403400
- Firm city
- Ft Lauderdale
- Firm state
- FL
- 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