Recall Z-0546-2007 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
GMP Companies/Lifesync Corporation
LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
| Date | Feb 27, 2007 (initiated Jan 10, 2007) |
| Status | Terminated |
| Reason | When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation. |
| Root cause | Other |
| Action | The recall was initiated on January 15, 2007. The firm''s representatives, hand carried, Device Recall Letter to Account Representative and Risk Manager. Distributors who received the Device Recall Letter, purged their stock of the affected devices and notified their customers. Recall Communication was hand carried to each account with 100% compliance by LifeSync Clinical/Sales Personnel. EFFECTIVENESS CHECKS of this recall will be achieved through Return Material Authorization via telephone with each affected account. |
| Quantity | 272 cases |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030795 | LIFESYNE SYSTEMS Gmp/Companies, Inc., Aug 5, 2003 |