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.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Lifesync Corporation
- Recall Initiated
- December 13, 2007
- Posted
- September 16, 2008
- Terminated
- October 1, 2008
- Recall Number
- Z-1659-2008
- Quantity
- 768 completed leadwire units
- Firm Location
- Ft Lauderdale, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Class II Recall - Nationwide Distribution.
Lot / Code Info
All lots
Root Cause
Nonconforming Material/Component
Action Taken
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.