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FDA Medical Device Recalls (openFDA)

Siemens Medical Solutions USA, Inc: Axiom Iconos R200 X-Ray

Recall number
Z-1213-2010
Recalling firm
Siemens Medical Solutions USA, Inc
Product
Axiom Iconos R200 X-Ray
Status
Terminated
Initiated
2010-01-29
Posted
2010-03-27
Terminated
2010-08-11
Reason
table can tilt/move when it is not intended
Root cause
Software design
Action
The recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device.
Quantity
169 units
Distribution
Nationwide Distribution.
Lot, serial or model codes
Model numbers 10093961, 5902767, 5902775, 5902783, 5902791, 5904086, 7152460, and 7152478
510(k) numbers
["K992660"]
PMA numbers
not on file
Product code
JAA
Firm FEI
2240869
Firm city
Malvern
Firm state
PA
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
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z

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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