Z-1364-2012

Siemens MAGNETOM Verio Use: Nuclear resonance imaging system

Name: Z-1364-2012 Siemens MAGNETOM Verio Use: Nuclear resonance imaging system
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-03-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-03-26 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens MAGNETOM Verio Use: Nuclear resonance imaging system on 2012-03-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1364-2012
Status: Terminated
Initiated: 2012-03-26
Posted: 2012-04-02
Terminated: 2014-04-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens MAGNETOM Verio Use: Nuclear resonance imaging system
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: manufacturing process
FDA root 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: [email protected] or Director, Product Complaints & Field Support at 610-448-4634 or email: [email protected].
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.
Product codes and lots: Model number 10276755

Product code LNH

K072237Class IIMagnetom VerioSiemens Medical Solutions USA, Inc. / cleared 2007-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)