Recalls / —
—#73842
Product
Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605.
- FDA product code
- IZI — System, X-Ray, Angiographic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K010721, K021021
- Affected lot / code info
- 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.
Why it was recalled
Incorrect contour finding: Image may be calibrated to the wrong size catheter.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2008-09-02
- Posted by FDA
- 2008-11-25
- Terminated
- 2009-10-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #73842. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.