MAMMOMAT Revelation, model no. 11343300 - Product Usage: is… recallZ-2388-2020 · Siemens Medical Solutions USA, Inc · initiated May 7, 2020
Class II Terminated All recalls posted in June 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 difficulty removing the vacuum biopsy system due to the device error, they should take the following actions to avoid potential risks: - The InSpect PV functionality should be deactivated by using a right mouse click, selecting PV option and choosing deactivate function. - Following this action, the normal biopsy mode remains active, and the tube head can be moved to the 15 degrees position, providing enough space to easily remove the vacuum needle out of the needle holder. Siemens Healthineers will provide a field software update VC10E for MAMMOMAT Revelation with VC10B, VC10C, and VC10D versions that will eliminate the issue described. This correction will be provided free of charge and is planned to be available in the third quarter of 2020. Your local Siemens Healthineers Service organization will contact you as soon as the software update is available for your system. Please feel free to contact firm's service organization for an earlier appointment at 1-800-888-7436. Customers were asked confirm acknowledgement of the information and instructions contained in the letter. If product was further distributed, please identify your customers and notify them of this recall.
Recall details
- Recall number
- Z-2388-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 7, 2020
- Posted by the FDA
- Jun 16, 2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 230 worldwide (64 US)
- Product code
- MUE
- FDA submissions
- K173408
- Distribution
- US Nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K173408 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MAMMOMAT Revelation 11343300Siemens Healthcare GmbH · Full field digital,system,x-ray,mammographic1 recall11 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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