Mammomat Revelation with software version VC10 and Biopsy Option… — Class II medical device recall Z-0160-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-10-30, distributed nationwide. An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become
| Recall number | Z-0160-2020 |
|---|---|
| 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 | 2019-07-23 |
| Classified | 2019-10-18 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2020-05-06 |
| Distributed | Nationwide (US) |
Product
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Reason for recall
An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
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-0160-2020. 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.