FDA Device recall Z-2388-2020
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and…
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and… by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2388-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-07 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers (distributed in the US): 1026 1057 1348 1426 1027 1274 1292 1360 1324 1728 1372 1744 1036…Serial Numbers (distributed in the US): 1026 1057 1348 1426 1027 1274 1292 1360 1324 1728 1372 1744 1036 1038 1620 1235 1751 1423 1379 1425 1342 1740 1445 1650 1058 1409 1277 1025 1253 1225 1749 1747 1422 1275 1228 1449 1707 1767 1387 1391 1206 1217 1250 1082 1357 1354 1256 1031 1339 1034 1219 1437 1289 1359 1045 1429 1408 1717 1051 ***Updated 8/18/2020*** 1775 1784 1785 1795 1797 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2388-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.