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Terminated

EM2 NC AEM Monitor (NON-COM)

FDA Recall Z-1050-03 · Posted 2003-07-24

Recalling FirmEncision, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2003-06-23
Date Terminated2003-11-06
Product Quantity21 units

Reason for Recall

Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.

Firm Action

Accounts were visited by sales representatives beginning 6/23/2003.

Root Cause

Other

Distribution Pattern

CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000480ACTIVE ELECTRODE MONITORING SYSTEMElectroscope, Inc. · 2000-05-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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