Reported Jun 11, 2014 · Terminated
Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355
Is this the product you have?
Siemens SOMATOM Emotion 16Emotion 6and SOMATOM Spirit Computed
- Tomography Systems Product UsageTo 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
- Lot codes and dates
- Material numbers
1016597710045692
- and 10165888 with serial numbers
32187311583121531222313133135432118321203212332125321263212732129321392916127229291852741527212293642918629165292332918227235293382917629376272322918127369292952723029198272442928629126273382930227231273342939429264321413215632159
- Material numbers
- Amount recalled
- 345
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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