Recalls / —

—#124762

Product

Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K103127, K113342, K120579, K122471

Affected lot / code info

models 8098027, 7740769, 10430603, 10590000, with multiple serial numbers: 64789, 64492, 66767, 66649, 64067, 66182, 65364, 64673, 64419, 66518, 66243, 64368, 64081, 60398, 66929, 66327, 66146, 66188, 66355, 66467, 64860, 64342, 73579, 73813, 64179, 66498, 64172, 66433, 66572,  66768, 64790, 66193, 64270, 66503, 65013, 65014, 64821, 64337, 64734, 65036, 66455, 66451, 66928, 65403, 65597, 64770, 66964, 66924, 64082,  66151, 66911, 65576, 67017, 64481, 64694, 66844, 73366, 64430, 65302,  64624, 66458, 60124, 66667, 64913, 64834, 73642, 66618, 66396, 66473, 73499, 64194, 64455, 60121, 64260, 66183, 64536, 83056, 64478, 65044, 60331,64424, 73738,64103,64232,64299,66851,66404,64929,64591,83014, 64114, 66381, 60404, 67000, 66422, 64181, 66490, 66738, 65225, 64308, 66253, 64822, 64484, 66757, 66679, 66616, 83059, 66813, 64603, 73679, 66695, 66878, 65948, 65572, 66248, 64304, 83044, 73160, 64019, 66375, 66689, 60173, 73030, 73655, 64504, 73818, 66112, 64882, 65341, 64243,  64297, 64378, 66824, 64370, 64340, 66445, 73547, 66462, 66882, 73761,  66316, 64927, 66694, 66700, 64071, 66634, 64827.

Why it was recalled

During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.

Root cause (FDA determination)

Software design

Action the firm took

A recall notification letter, dated November 15, 2013, was sent to Users.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide Distribution.

Timeline

Recall initiated

2013-11-15

Posted by FDA

2014-02-03

Terminated

2015-03-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #124762. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.