SOMATOM Emotion 16. Computed tomography X-ray system recallZ-2453-2008 · Siemens Medical Solutions USA, Inc · initiated Aug 5, 2008
Terminated All recalls posted in September 2008
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
Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm issued and Safety Update in July 2008 informing users that the firm will have representatives visit each account to replace the cap per Update Instructions CT032/08/S.
Recall details
- Recall number
- Z-2453-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 5, 2008
- Posted by the FDA
- Sep 21, 2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 53 units
- Product code
- JAK
- FDA submissions
- K050297
- Distribution
- Nationwide including states of AK, AL, CO, FL, GA, IA, ID, IL, IN, LA, MD, MN, MS, NC, NE, NY, OH, OK, OR, RI, SD, TX, UT, WA, and WI.
Product description
SOMATOM Emotion 16. Computed tomography X-ray system
Code information (models, lots, serial numbers)
Model Numbers: 10165888, 10165977, and 10046789.
Other devices under the same FDA submission
2 devices cleared under 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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