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.
FDA Recall Z-1659-2008 · Posted 2008-09-16
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Recalling FirmLifesync Corporation
Recall StatusTerminated
Product CodeDRG
Date Initiated2007-12-13
Date Terminated2008-10-01
Product Quantity768 completed leadwire units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Class II Recall - Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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