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U.S. Department of Health and Human Services

Class 3 Device Recall Beekley Spots Light Image OSpots

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  Class 3 Device Recall Beekley Spots Light Image OSpots see related information
Date Initiated by Firm June 19, 2013
Date Posted June 13, 2014
Recall Status1 Terminated 3 on June 16, 2014
Recall Number Z-1787-2014
Recall Event ID 65483
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
Product Beekley Spots Light Image O-Spots for Mammography
Catalog Number: 252

Product Usage: To identify raised moles in Mammography
Code Information Lot Number: 252.04261301
Recalling Firm/
Manufacturer		 Beekley Corporation
1 Prestige Ln
Bristol CT 06010-7468
For Additional Information Contact
800-233-5539
Manufacturer Reason
for Recall		 Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
FDA Determined
Cause 2		 Error in labeling
Action Beekley sent an Urgent Medical Device Recall letters dated June 19, 2013 via FedEx with signature and tracking confirmation. The letter identified the affected product, problem and actions to be taken. Firm requests users to examine inventory, remove and return recalled product. For questions contact Chelsea Fuller, Regulatory Manager at 1-800-233-5539 x 491
Quantity in Commerce 81 boxes
Distribution Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA.
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.
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