medical Class II Updated 2019-10-30

Siemens Medical Solutions USA, Inc recalls Mammomat Revelation with software version VC10 and Biopsy Op

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: software version VC10 and Biopsy Option
View official government recall

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