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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = LNH
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