Siemens SOMATOM Definition recall: Software Issue
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Why was Siemens SOMATOM Definition 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 147
- Distribution
- Nationwide Distribution.
- Recall date
- February 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)