Siemens Medical Solutions USA, Inc recalls Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagno…

Recall date

July 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0160-2020

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures