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U.S. Department of Health and Human Services

Class 2 Device Recall Breast Biopsy Aiming Device

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  Class 2 Device Recall Breast Biopsy Aiming Device see related information
Date Initiated by Firm October 05, 2005
Date Posted November 15, 2005
Recall Status1 Terminated 3 on August 07, 2007
Recall Number Z-0138-06
Recall Event ID 33921
510(K)Number K010773  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
Code Information Model number 5728735
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. This could result in a biopsy being performed at an incorrect location and presents the possibility of an inconclusive diagnosis. calculation of offset values for the breast biopsy aiming device may be incorrect
FDA Determined
Cause 2		 Other
Action The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions MR034/05/S. The letter re-emphasizes the importance of printing the offset values on the worksheet prior to moving the patient table and in accordance with the User's Manual.
Quantity in Commerce 16 units
Distribution The product was shipped to medical facilities in CA, FL, IL, MD, MN, NM, OH, OR, RI, and WI.
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 = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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