—#126673

Product

Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023687, K042328, K050297
Affected lot / code info: Material numbers: 10165977, 10045692 , and 10165888 with serial numbers: 32187 31158 31215 31222 31313 31354 32118 32120 32123 32125 32126 32127 32129 32139 29161 27229 29185 27415 27212 29364 29186 29165 29233 29182 27235 29338 29176 29376 27232 29181 27369 29295 27230 29198 27244 29286 29126 27338 29302 27231 27334 29394 29264 32141 32156 32159

Why it was recalled

The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.

Root cause (FDA determination)

Component design/selection

Action the firm took

Siemens sent a Customer Safety Advisory Notice/ Field Safety Notice letter dated March 21, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that the system modification would be implemented by Siemens service specialists in April 2014 to correct the problem.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR.

Timeline

Recall initiated: 2014-03-21
Posted by FDA: 2014-06-04
Terminated: 2015-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126673. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.