Siemens MAGNETOM Verio Use: Nuclear resonance imaging system

FDA device recall Z-1364-2012 · posted 2012-04-02 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LNH

Quantity affected

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,

Date initiated

2012-03-26

Date posted

2012-04-02

Date terminated

2014-04-03

Location

Malvern, PA

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