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Recall Observatory FDA recall evidence

Device 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.

Z-1721-2014

March 21, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 67967
Status
Terminated
Classification
Class II
Quantity
345
Official record key
device-enforcement:Z-1721-2014

Official wording

Reason: 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.

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.