Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2832-2018 · Posted None

Recalling FirmBeekley Corporation
Recall StatusTerminated
Product CodeJAC
Date Initiated2018-06-13
Date Terminated2018-11-13
Product Quantity3,384,024 pieces in total.

Reason for Recall

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

Firm Action

On June 14, 2018, Beekley Medical issued an "URGENT MEDICAL DEVICE RECALL" notice dated June 13, 2018 to customers. The notice described the products, problem and actions to be taken. Customers are advised to do the following: - Inspect stock and quarantine affected product - complete and return the acknowledgement response form via fax to: 1-800-735-1234 or mail. - contact firm if inventory of affected product remains with customers at 1-800-233-5539 between 8:00am - 5:30pm EDT. If you have any issues occurred or for further question, contact Quality Assurance & Regulatory Manager at 1-800-233-5539x434.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑