Class 2 Device Recall Siemens MAGNETOM Verio

• Date Initiated by Firm: March 26, 2012
• Date Posted: April 02, 2012
• Recall Status: Terminated on April 03, 2014
• Recall Number: Z-1364-2012
• Recall Event ID: 61488
• 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 PA 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: 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 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.