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U.S. Department of Health and Human Services

Class 2 Device Recall LifeSync Disposable LeadWear

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 Class 2 Device Recall LifeSync Disposable LeadWearsee related information
Date Initiated by FirmDecember 13, 2007
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on October 01, 2008
Recall NumberZ-1660-2008
Recall Event ID 47336
510(K)NumberK030795 
Product Classification ECG Radiofrequency transmitter/receiver - Product Code DRG
ProductLS-202 Large LeadWear Combo 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.
Code Information All Lots
Recalling Firm/
Manufacturer		 Lifesync Corporation
One E. Broward Blvd.
Suite 1701
Ft Lauderdale FL 33301
For Additional Information Contact
954-745-3510
Manufacturer 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, 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
FDA Determined
Cause 2		Nonconforming Material/Component
ActionFirm 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 Commerce576 completed leadwire units
DistributionClass II Recall - Nationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DRG
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