Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Mammography skin markers

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Mammography skin markers see related information
Date Initiated by Firm June 13, 2018
Create Date August 16, 2018
Recall Status1 Terminated 3 on November 13, 2018
Recall Number Z-2832-2018
Recall Event ID 80558
Product Classification System, x-ray, film marking, radiographic - Product Code JAC
Product TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S

Adhere to skin for marking and identifying moles in mammography.
Code Information REF 782 - Lot Numbers:  05311801 05211801 02221801 04181802 03051801 03071802 04181804 05081801 03131801 02121801 03301802 05141801 03141801 05101801 03271801 05161801 02161801 03021802 04111801 05011801 05171802 02211801 04051802 04271801 04251801 05161802 03141802 05181801 04121801 05221802 04161802 04171801 04181803 05301802 04241802 05011802 02271802 02271803 02071802 02261802 02261803 05291803  REF 782S - Lot Numbers: 02221801 03271801 04121801  REF 783 - Lot Numbers: 04131801 03071801 02281801 03121801 05151801 04101801 05041801 03021801 05181803 02081801 03261801 05221801 02061801 04181801 04201801 05071801 03161801 04061801 05181802 04231802 03091802 03171801  REF 783S - Lot Numbers: 02221801 04021801  REF 784 - Lot Numbers: 05231801 03061801 02261801 03211801 02141801 03211802 05091801 04261802  REF 784S - Lot Numbers: 02221801 04021801 04121801  REF 785 Lot Numbers:  05111801 04191801  REF 785S Lot Numbers: 04021801 04121801    
Recalling Firm/
Manufacturer		 Beekley Corporation
1 Prestige Ln
Bristol CT 06010-7468
For Additional Information Contact
860-583-4700
Manufacturer Reason
for Recall		 There is a potential for imaging artifact to mimic calcifications on patient's mammograms
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 3,384,024 pieces in total.
Distribution Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-