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U.S. Department of Health and Human Services

Class 2 Device Recall MAGNETOM Verio

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  Class 2 Device Recall MAGNETOM Verio see related information
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
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
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
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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