Recall Z-0160-2020 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
| Date | Jul 23, 2019 |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | Siemens issued the customer notification on 7/23/19 via XP018/19/S. The Advisory Notice provides the problem, health risk and action to take: provided steps to the operator on how to easily release patient and proceed with exam. Siemens is developing a corrective action to resolve the issue, which will be released via Update Instruction XP021/19/S. |
| Quantity | 139 WW (33 US) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173408 | Mammomat Revelation Siemens Medi Cal Solutions, Inc., Mar 21, 2018 |