# FDA recall Z-1343-2020

> **Hologic, Inc.** · Class II · device recall initiated 2020-01-21.

## Product

Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,

## Reason for recall

The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.

## Distribution

Domestic distribution to 14 states: AK  AZ  CA  CO  CT  DC  FL  GA  IA  ID  IL  MA  MO  NC  NH  NJ  NY  OH  SD  TX  VA. Foreign distribution to Italy, United Kingdom, Saudi Arabia, Brazil, Costa Rica, Spain, Canada, Cyprus, Germany, France, Korea, Kuwait, The Netherlands, Oman, Peru, and Russia.

## Key facts

- **Recall number:** Z-1343-2020
- **Recalling firm:** Hologic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-21
- **Report date:** 2020-03-04
- **Termination date:** 2021-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danbury, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1343-2020

## Citation

> AI Analytics. FDA recall Z-1343-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1343-2020. Source: US FDA. Licensed CC0.

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