FDA recall Z-0160-2020

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-07-23

Report date

2019-10-30

Termination date

2020-05-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2020