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

Recall date

June 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2832-2018

FDA classification

Class II

Brand / firm

Beekley Corporation

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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