Date Initiated by Firm | December 13, 2007 |
Date Posted | September 16, 2008 |
Recall Status1 |
Terminated 3 on October 01, 2008 |
Recall Number | Z-1660-2008 |
Recall Event ID |
47336 |
510(K)Number | K030795 |
Product Classification |
ECG Radiofrequency transmitter/receiver - Product Code DRG
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Product | LS-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
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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 |
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 | 576 completed leadwire units |
Distribution | Class II Recall - Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DRG
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