FDA Medical Device Recalls (openFDA)
Encision, Inc.: EM2+A NC AEM Monotor (NON-COM)
- Recall number
- Z-1051-03
- Recalling firm
- Encision, Inc.
- Product
- EM2+A NC AEM Monotor (NON-COM)
- Status
- Terminated
- Initiated
- 2003-06-23
- Posted
- 2003-07-24
- Terminated
- 2003-11-06
- 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
- 4 units
- Distribution
- CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
- Lot, serial or model codes
- Catalog number EM2+A NC, all serial numbers.
- 510(k) numbers
- ["K000480"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000117361
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28