EM2 NC AEM Monitor (NON-COM)
This recall has been terminated (originally issued July 24, 2003).
- Company
- Encision, Inc.
- Recall Initiated
- June 23, 2003
- Posted
- July 24, 2003
- Terminated
- November 6, 2003
- Recall Number
- Z-1050-03
- Quantity
- 21 units
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
Distribution
CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
Lot / Code Info
Catalog Number EM2 NC, all serial numbers.
Root Cause
Other
Action Taken
Accounts were visited by sales representatives beginning 6/23/2003.
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