Z-0546-2007

LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223

Name: Z-0546-2007 LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
Creator: GMP Companies/Lifesync Corporation
Published: 2007-01-10
License: https://open.fda.gov/license/

LifeSync Corporation / initiated 2007-01-10 / Terminated

FDA source

GMP Companies/Lifesync Corporation began a recall of LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223 on 2007-01-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0546-2007
Status: Terminated
Initiated: 2007-01-10
Posted: 2007-02-27
Terminated: 2009-07-27
Recalling firm: LifeSync Corporation
Product: LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
Product code: DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Reason for recall: 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.
FDA 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 in commerce: 272 cases
Distribution: Nationwide
Product codes and lots: C6310, C6324 and C6297.

Product code DRG

K030795Class IILifesyne SystemsGmp/Companies, Inc. / cleared 2003-08-05

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)