Siemens Mammomat Inspiration Recall for Potential System Fatal Error
Siemens is recalling 76 Mammomat Inspiration units because a system fatal error may occur during tomosynthesis reconstruction for large breasts, causing the process to abort.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, a Class II recall without reported hospitalizations or injuries falls under the 'High' category (Score 3), representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 76 units of the Mammomat Inspiration with Tomosynthesis functionality (Model number: 10140000). The recall is due to a potential system fatal error that may occur during tomosynthesis reconstruction. This issue is specific to large breasts that cover nearly the entire detector surface and have a thickness larger than 90 mm.
The hazard arises because the data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, the reconstruction of the data will be aborted. The source text does not report any injuries or illnesses associated with this defect.
The affected units were distributed nationwide, including Puerto Rico, and to the states of AR, CA, CO, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA, and WI. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this issue.
The recalled product
- Product
- Mammomat Inspiration with Tomosynthesis functionality
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 76
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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