Recall Z-2388-2020 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
| Date | Jun 16, 2020 (initiated May 7, 2020) |
| Status | Terminated |
| Reason | If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system. |
| Root cause | Device Design |
| Action | On May 7, 2020, the firm distributed Urgent Medical Device Correction letters to all affected customers. Customers were informed of the potential issue on their MAMMOMAT Revelation system with software versions VC10B, VC10C, or VC10D with Tomo Biopsy Unit option and the InSpect functionality, and the relevant corrective action that would be performed on these systems to prevent possible hazard to patients. The firm stated they do not consider it necessary to re-examine any patients in this case as the error had no influence on the previous treatment of patients. If the operator experiences d |
| Quantity | 230 worldwide (64 US) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173408 | Mammomat Revelation Siemens Medi Cal Solutions, Inc., Mar 21, 2018 |