Device product
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Z-0160-2020
Product summary
- Event
- Event 83508
- Status
- Terminated
- Classification
- Class II
- Quantity
- 139 WW (33 US)
- Official record key
device-enforcement:Z-0160-2020
Official wording
Reason: 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
Code information: software version VC10 and Biopsy Option
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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