Reported Jun 24, 2020 · Terminated
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening,…
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
Is this the product you have?
- MAMMOMAT Revelation, model no. 11343300 -
- Product Usageis intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals
- Lot codes and dates
- Serial Numbers (distributed in the US)***Updated 8/18/2020*** 1775 1784 1785 1795 1797
10261057134814261027127412921360132417281372174410361038162012351751142313791425134217401445165010581409127710251253122517491747142212751228144917071767138713911206121712501082135713541256103113391034121914371289135910451429140817171051
- Serial Numbers (distributed in the US)
- Amount recalled
- 230 worldwide (64 US)
Where it was sold
- Nationwide
Why it was recalled
If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
This product could cause temporary or reversible health problems — stop using it.
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