FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1659-2008
- Recalling firm
- Lifesync Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2007-12-13
- Posted
- 2008-09-16
- Terminated
- 2008-10-01
- 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.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K030795"]
- PMA numbers
- not on file
- Product code
- DRG
- Firm FEI
- 1000403400
- Firm city
- Ft Lauderdale
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28