Z-1659-2008

LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a...

Name: Z-1659-2008 LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a...
Creator: Lifesync Corporation
Published: 2007-12-13
License: https://open.fda.gov/license/

LifeSync Corporation / initiated 2007-12-13 / Terminated / root cause: manufacturing process

FDA source

Lifesync Corporation began a recall of LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of... on 2007-12-13. The reason FDA records is "LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, leading to a possible...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1659-2008
Status: Terminated
Initiated: 2007-12-13
Posted: 2008-09-16
Terminated: 2008-10-01
Recalling firm: LifeSync Corporation
Product: LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been validated for compatibility.
Product code: DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Reason for recall: LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, leading to a possible delay in treatment based upon a delay in ECG monitoring.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Firm issued a Device Recall Letter on 12/14/2007. Users were requested to remove the product from inventory and discontinue use of the Large Sized LeadWear with the 12 Lead Adaptors. The current stock of product in inventory will be held under a stop shipment, pending destruction of non-conforming product.
Quantity in commerce: 768 completed leadwire units
Distribution: Class II Recall - Nationwide Distribution.
Product codes and lots: All lots

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)