Siemens Medical Solutions USA, Inc Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
model number: 10140000
Products Sold
model number: 10140000
Siemens Medical Solutions USA, Inc is recalling Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereo due to It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026