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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens MAGNETOM Verio

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 Class 2 Recall
Siemens MAGNETOM Verio
see related information
Date Posted April 02, 2012
Recall Status1 Terminated on April 03, 2014
Recall Number Z-1364-2012
Recall Event ID 61488
Premarket Notification
510(K) Number
K072237 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Siemens MAGNETOM Verio Use: Nuclear resonance imaging system
Code Information Model number 10276755
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall
During product monitoring, Siemens has discovered that the gradient cable connections on a few systems did not meet their specifications after installation. The cable connections overheated, leading to the emission of smoke and possible material damage.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Siemens Medical Solutions USA, Inc., sent a "Customer Safety Advisory Notice" including Update Instruction MR028/10/S dated March 2012 to affected customers via hand delivery by Siemens Service Engineer . The notice described the product, problem and actions to be taken. The customers were instructed to create a COBR image and to make a copy of the attached "Completion Protocol" fill it out and file in their corresponding binder. Siemens Service Engineer performed an all gradient cable connection visual inspection as well as torque check on the connecting screws at the sites and the factory prior to their release to the field. Siemens also issued a current Update Instruction MR024/11/S. If you have any questions regarding this report, please contact the Quality Engineer, Product Complaints & Field Support at 610-219-4834; email: anastasia.mason@siemens.com or Director, Product Complaints & Field Support at 610-448-4634 or email: josephine.mcbride@siemens.com.
Quantity in Commerce 245
Distribution Nationwide distribution to Washington, DC and the following States: AL, AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WI. Government Accounts include: BROOKE ARMY MEDICAL CENTER, 3851 ROGER BROOKE DR, FORT SAM HOUSTON, TX 78234; NATIONAL INSTITUTE OF HEALTH, 10 CENTER DRIVE, BETHESDA, MD 20892; NAVAL MEDICAL CENTER, 34800 BOB WILSON DR, SAN DIEGO, CA 92134; US AIR FORCE REGIONAL HOSPITAL, 5955 ZEAMER AVE, ANCHORAGE, AK 99506; VA MEDICAL CENTER, 3350 LA JOLLA VILLAGE DR, SAN DIEGO, CA 92161; VA MEDICAL CENTER, 830 CHALKSTONE AVE, PROVIDENCE, RI 02908; VA MEDICAL CENTER, 109 BEE ST, CHARLESTON, SC 29403; VA MEDICAL CENTER, 10000 BAY PINES BLVD, BAY PINES, FL 33744; VA MEDICAL CENTER, 800 BAILIE DR, AUGUSTA, GA 30901; VA MARTINEZ 612, 150 MUIR RD, MARTINEZ, CA 94553; VA MEDICAL CENTER, 1501 SAN PEDRO SE, ALBUQUERQUE, NM 87108; VA MEDICAL CENTER, 1670 CLAIRMONT RD, DECATUR, GA 30033; VA MEDICAL CENTER - ST LOUIS, 915 N GRAND AVE, ST LOUIS, MO 63106; and VA MEDICAL CENTER HARLINGEN, 2106 TREASURE HILLS BLVD, HARLINGEN, TX 78550. "Other" is National Institute of Health.
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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