[Recalled] TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography. — There is a potential for imaging artifact to mimic calcifications on patient's… | FDA 2018-06-13

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There is a potential for imaging artifact to mimic calcifications on patient's mammograms

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Beekley Corporation

• S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography. — Class II
• Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography — Class III
• Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain — Class II
• Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern — Class II
• Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate. — Class II
• Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.