FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens MAGNETOM Verio Use: Nuclear resonance imaging system
- Recall number
- Z-1364-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens MAGNETOM Verio Use: Nuclear resonance imaging system
- Status
- Terminated
- Initiated
- 2012-03-26
- Posted
- 2012-04-02
- Terminated
- 2014-04-03
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Model number 10276755
- 510(k) numbers
- ["K072237"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28