Beekley Corporation recalls TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammogr

Recalled August 22, 2018 · FDA recall Z-2832-2018 · Beekley

Hazard

There is a potential for imaging artifact to mimic calcifications on patient's mammograms · FDA Class II

Units

3,384,024 pieces in total.

Sold at

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

Description

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

Product

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

Manufacturer(s)

Beekley Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →