SOMATOM Emotion 16 recallZ-1933-2015 · Siemens Medical Solutions USA, Inc · initiated Jun 4, 2015
Class II Terminated All recalls posted in June 2015
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
A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
FDA root cause category: Device Design
What the company is doing
A safety advisory notice, dated June 4, 2015, was sent to direct accounts explaining the problem and potential risk to patients and operators. Siemens engineers will begin replacing the bolts in May 2015.
Recall details
- Recall number
- Z-1933-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 4, 2015
- Posted by the FDA
- Jun 27, 2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 40 total
- Product code
- JAK
- FDA submissions
- K133424
- Distribution
- Nationwide Distribution.
Product description
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Code information (models, lots, serial numbers)
model numbers: 10165977, with serial numbers: 32310 32254 32322 32317 32303 32295 32327 32309 32319 32237 32326 32259 32323 32257 32298 32315 32268 32244 32252 32293 32349 32313 32334 32301 32339 32277 32292 32281 32273 32320 32324 32346 32270
Other devices under the same FDA submission
1 device cleared under K133424 — 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 6-slice configuration 10165888Siemens Shanghai Medical Equipment Ltd. · System, x-ray, tomography, computed1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 71484).
- Z-1934-2015 · TerminatedSOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or sp…
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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