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U.S. Department of Health and Human Services

Class 2 Device Recall MAGNETOM Verio

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 Class 2 Recall
MAGNETOM Verio
see related information
Date Posted February 23, 2011
Recall Status1 Terminated on September 25, 2012
Recall Number Z-1401-2011
Recall Event ID 57781
Premarket Notification
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, Pennsylvania 19355
Consumer Instructions Contact the recalling firm for information
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/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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