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Class 3 Device Recall Magnetom Allegra |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
December 18, 2003 |
Date Posted |
February 10, 2004 |
Recall Status1 |
Terminated 3 on November 09, 2004 |
Recall Number |
Z-0522-04 |
Recall Event ID |
28046 |
510(K)Number |
K002179
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Product |
Magnetom Allegra System. Nuclear Magnetic Resonance Imaging Diagnostic Device |
Code Information |
Model #7106433 - Serial #''s 20101 through 20113. Model #7387736 - Serial #''s 20405, 20406, 20411, 20412, and 20419 |
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 610-448-17777
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Manufacturer Reason for Recall |
tissue roll can become magnetic
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm has issued Updated Instructions to replace the stainless steel tissue roll holder. The recalling firm''s representatives are visiting each account to replace the tissue roll holder. |
Quantity in Commerce |
16 units |
Distribution |
The product was shipped to medical facilities in CA, CT, DC, FL, GA, IL, IN, KS, KY, MA, MD, MN, NC, NY, OH, OR, PA, TX, and UT. |
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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 = and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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