MAMMOMAT Revelation — Class II medical device recall Z-2388-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-06-24, distributed nationwide. If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system
| Recall number | Z-2388-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2020-05-07 |
| Classified | 2020-06-16 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2022-09-29 |
| Distributed | Nationwide (US) |
| Serial numbers | 1025, 1026, 1027, 1031, 1034, 1036, 1038, 1045, 1051, 1057, 1058, 1082, 1206, 1217, 1219, 1225, 1228, 1235, 1250, 1253, 1256, 1274, 1275, 1277, 1289 and 39 more |
| Model numbers | 11343300 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2388-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.