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U.S. Department of Health and Human Services

Class 2 Device Recall Affirm Lateral Arm Upright Biopsy Accessory

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  Class 2 Device Recall Affirm Lateral Arm Upright Biopsy Accessory see related information
Date Initiated by Firm July 07, 2017
Create Date January 14, 2018
Recall Status1 Terminated 3 on April 04, 2018
Recall Number Z-0351-2018
Recall Event ID 78777
510(K)Number K161575  
Product Classification Biopsy needle guide kit - Product Code OIJ
Product Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Code Information UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
Recalling Firm/
Manufacturer		 Hologic, Inc.
36 and 37 Apple Ridge Rd
Danbury CT 06810-7301
For Additional Information Contact
203-207-4500
Manufacturer Reason
for Recall		 The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
FDA Determined
Cause 2		 Component change control
Action Letter
Quantity in Commerce 12 (U.S.)
Distribution US and OUS
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.
510(K) Database 510(K)s with Product Code = OIJ and Original Applicant = HOLOGIC
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