Siemens Mammomat Inspiration System Recalled for Potential Instability
Siemens is recalling three Mammomat Inspiration systems because the workstation table may fall over if not secured, posing a risk of serious injury.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the hazard may result in a 'serious injury' to the operator, which aligns with the rubric criteria for a score of 4 (Severe) involving significant injury reports or risks.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three units of the Mammomat Inspiration system, model number 10140000. These systems are used for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
The recall was issued because if the system is not secured to the floor and the monitors are positioned too far from the table top, the Acquisition Workstation (AWS) table may become unstable and fall over. This instability presents a potential risk of serious injury to the operator.
The affected units were distributed in West Virginia, New York, and Florida. Medical professionals using these systems should contact Siemens for further instructions regarding the recall.
The recalled product
- 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.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- model number: 10140000
Distribution
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