Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit… recallZ-1721-2014 · Siemens Medical Solutions USA, Inc · initiated Mar 21, 2014
Class II Terminated All recalls posted in June 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-1721-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 21, 2014
- Posted by the FDA
- Jun 4, 2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 345
- Product code
- JAK
- FDA submissions
- K023687, K042328, K050297
- Distribution
- US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR.
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
2 devices cleared under K023687, K042328, K050297 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SOMATOM Emotion 16-slice configuration 10165977Siemens Shanghai Medical Equipment Ltd. · System, x-ray, tomography, computed2 reports
- SOMATOM Emotion 16 Slice (DE) 10046789Siemens Healthcare GmbH · System, x-ray, tomography, computed2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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