# FDA recall Z-2388-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-05-07.

## 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 for recall

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2388-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-07
- **Report date:** 2020-06-24
- **Termination date:** 2022-09-29

- **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-2388-2020

## Citation

> AI Analytics. FDA recall Z-2388-2020. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2388-2020. Source: US FDA. Licensed CC0.

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