Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is in…

Recall date
January 11, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1118-2017
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
United States Nationwide Distribution

Why it was recalled

Software error

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 interpreted by either hard copy film or soft copy workstation.

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