Recall Z-1659-2008 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Lifesync Corporation
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.
| Date | Sep 16, 2008 (initiated Dec 13, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 768 completed leadwire units |
| Distribution | Class II Recall - Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030795 | LIFESYNE SYSTEMS Gmp/Companies, Inc., Aug 5, 2003 |