FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605.
- Recall number
- Z-0122-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605.
- Status
- Terminated
- Initiated
- 2008-09-02
- Posted
- 2008-11-25
- Terminated
- 2009-10-05
- Reason
- Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Root cause
- Software design
- Action
- Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.
- Quantity
- 133 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Model number 7008605. Serial numbers: 55001, 55003, 55019, 55021, 55036, 55037, 55043, 55048, 55138, 55162, 55166, 55181, 55242, 55255, 55264, 55266, 55278, 55280, 55288, 55298, 55323, 55333, 55341, 55347, 55349, 55350, 55351, 55358, 55361, 55368, 55377, 55378, 55386, 55396, 55397, 55399, 55402, 55407, 55408, 55409, 55410, 55411, 55412, 55414, 55415, 55416, 55417, 55418, 55419, 55420, 55421, 55422, 55423, 55424, 55425, 55426, 55427, 55428, 55429, 55430, 55431, 55432, 55433, 55434, 55435, 55436, 55437, 55438, 55439, 55440, 55441, 55442, 55443, 55444, 55445, 55446, 55447, 55448, 55449, 55450, 55452, 55453, 55454, 55455, 55456, 55457, 55458, 55459, 55460, 55461, 55462, 55463, 55464, 55465, 55466, 55467, 55468, 55470, 55471, 55472, 55473, 55474, 55476, 55477, 55478, 55479, 55480, 55481, 55482, 55483, 55484, 55485, 55486, 55487, 55488, 55489, 55490, 55492, 55493, 55494, 55495, 55496, 55497, 55498, 55499, 55500, 55501, 55502, 55503, 55504, 55506, and 55507.
- 510(k) numbers
- ["K010721","K021021"]
- PMA numbers
- not on file
- Product code
- IZI
- 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
- 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