| Class 2 Device Recall MAGNETOM Verio | |
Date Initiated by Firm | January 10, 2011 |
Date Posted | February 23, 2011 |
Recall Status1 |
Terminated 3 on September 25, 2012 |
Recall Number | Z-1401-2011 |
Recall Event ID |
57781 |
510(K)Number | K072237 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product | MAGNETOM Verio
Nuclear magnetic resonance imaging |
Code Information |
Model number 10276755 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact | Meredith A. Adams 610-219-6300 |
Manufacturer Reason for Recall | On some systems the gradient cable connections did not meet firm's specifications after installation |
FDA Determined Cause 2 | Other |
Action | Siemens Medical Solutions USA, Inc sent customers a letter on January 10, 2011 notifying them of an Update Instruction and informing them that recalling firm would preventatively check the gradient cable connections of all systems. For questions regarding this recall call 610-219-6300. |
Quantity in Commerce | 92 |
Distribution | Nationwide Distribution including AK, AZ, CA, CT, FL, HI, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NV, OH, OK, OR, PA, RI, TN, TX, VA, WI, and WV |
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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