SOMATOM CT System Emotion 16. Computed tomography x-ray… recallZ-0793-06 · Siemens Medical Solutions USA, Inc · initiated Mar 9, 2006
Terminated All recalls posted in April 2006
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
When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.
FDA root cause category: Other
What the company is doing
The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue.
Recall details
- Recall number
- Z-0793-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 9, 2006
- Posted by the FDA
- Apr 26, 2006
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 5 units
- Product code
- JAK
- FDA submissions
- K050297
- Distribution
- Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI.
Product description
SOMATOM CT System Emotion 16. Computed tomography x-ray system.
Code information (models, lots, serial numbers)
Emotion 16 model number 7734713 with serial numbers 39049, 39050, 39012, 39015 and 39077
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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