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FDA Medical Device Recalls (openFDA)

Nihon Kohden America Inc: AG-920RA Multi-gas unit analyzer

Recall number
Z-0506-04
Recalling firm
Nihon Kohden America Inc
Product
AG-920RA Multi-gas unit analyzer
Status
Terminated
Initiated
2003-12-05
Posted
2004-01-31
Terminated
2004-02-17
Reason
Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough.
Root cause
Other
Action
Consignees were notified on 12/5/03. All have received return authorizations.
Quantity
24
Distribution
CA, OK, NV
Lot, serial or model codes
Serial numbers 00001 to 00020, 00022, 00023, 00024, 00029.
510(k) numbers
not on file
PMA numbers
not on file
Product code
CCK
Firm FEI
2080783
Firm city
Foothill Ranch
Firm state
CA
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

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