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Siemens Medical Solutions USA, Inc recalls Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diag
Recalled October 30, 2019 · FDA recall Z-0160-2020 · Siemens Medical Solutions USA
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 · FDA Class II
Units
139 WW (33 US)
Sold at
Nationwide
Description
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
Product
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →