# FDA recall Z-2832-2018

> **Beekley Corporation** · Class II · device recall initiated 2018-06-13.

## Product

TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S     Adhere to skin for marking and identifying moles in mammography.

## Reason for recall

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

## Distribution

Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.

## Key facts

- **Recall number:** Z-2832-2018
- **Recalling firm:** Beekley Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-13
- **Report date:** 2018-08-22
- **Termination date:** 2018-11-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2832-2018

## Citation

> AI Analytics. FDA recall Z-2832-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2832-2018. Source: US FDA. Licensed CC0.

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