Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| 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. |
| Quantity | 230 worldwide (64 US) |
| Distribution | US Nationwide distribution. |
| Initiated | 2020-05-07 |
| Classified | 2020-06-16 |
| Terminated | 2022-09-29 |
| Recall number | Z-2388-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-2388-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85719/
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