FDA-Device2019-10-30Class II
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Siemens Medical Solutions USA, Inc
Hazard
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
Sold states
Nationwide
Affected count
139 WW (33 US)
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief