Siemens Mammomat Inspiration Mammography Systems Recalled for Software Error
Siemens Medical Solutions USA is recalling 55 Mammomat Inspiration digital x-ray mammography systems due to a software error.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary, firm-initiated action for a software error with no reported injuries or illnesses in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is voluntarily recalling 55 units of the Mammomat Inspiration full-field digital x-ray mammographic system. The recall was initiated on January 11, 2017, and is classified as Class II by the U.S. Food and Drug Administration. The reason for the recall is a software error.
The affected devices are intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. The systems were distributed nationwide in the United States. The recall was terminated on November 29, 2017.
Healthcare facilities and consumers should check their device model number (10140000) and serial numbers against the list provided in the official recall notice to determine if their equipment is affected. Siemens notified affected parties via letter.
The recalled product
- Product
- Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 55
Distribution
Distributed nationwide across the United States.
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