Reported Oct 30, 2019 · Terminated
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: 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 · 19355-1418
Is this the product you have?
- Mammomat Revelation with software version
- VC10 and Biopsy Option Intended UseFor mammography exams, screening, diagnostics, biopsies and dual energy procedures
- Lot codes and dates
- software version VC10 and Biopsy Option
- Amount recalled
- 139 WW (33 US)
Where it was sold
- Nationwide
Why it was recalled
An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
This product could cause temporary or reversible health problems — stop using it.
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