Reported Feb 8, 2017 · Terminated
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Mammomat Inspiration full, field digital,system,x-ray
- mammographic Product UsageThe 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
- Lot codes and dates
- Device Model # 10140000
- Serial Numbers
4709661665716602676165734520455665676424630667576560652464126442501866758038657560453122687132434571625964696676647466406452656168012098416164836344628865948002661063944018650260804214689360933118660150426246308845256870
- Amount recalled
- 55 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Software error
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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