Recall Z-1052-03 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Encision, Inc.
EM2M NC AEM Monitor, (NON-COM)
| Date | Jul 24, 2003 (initiated Jun 23, 2003) |
| Status | Terminated |
| Reason | Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes. |
| Root cause | Other |
| Action | Accounts were visited by sales representatives beginning 6/23/2003. |
| Quantity | 2 units |
| Distribution | CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000480 | ACTIVE ELECTRODE MONITORING SYSTEM Electroscope, Inc., May 2, 2000 |