Z-1050-03

EM2 NC AEM Monitor (NON-COM)

Name: Z-1050-03 EM2 NC AEM Monitor (NON-COM)
Creator: Encision, Inc.
Published: 2003-06-23
License: https://open.fda.gov/license/

Encision, Inc. / initiated 2003-06-23 / Terminated

FDA source

Encision, Inc. began a recall of EM2 NC AEM Monitor (NON-COM) on 2003-06-23. The reason FDA records is "Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1050-03
Status: Terminated
Initiated: 2003-06-23
Posted: 2003-07-24
Terminated: 2003-11-06
Recalling firm: Encision, Inc.
Product: EM2 NC AEM Monitor (NON-COM)
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
FDA root cause: Other
Action: Accounts were visited by sales representatives beginning 6/23/2003.
Quantity in commerce: 21 units
Distribution: CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
Product codes and lots: Catalog Number EM2 NC, all serial numbers.

Product code GEI

K000480Class IIActive Electrode Monitoring SystemElectroscope, Inc. / cleared 2000-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)