# FDA recall Z-0160-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-07-23.

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0160-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-23
- **Report date:** 2019-10-30
- **Termination date:** 2020-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2020

## Citation

> AI Analytics. FDA recall Z-0160-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0160-2020. Source: US FDA. Licensed CC0.

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