Recalls / —

—#97383

Product

MAGNETOM Verio Nuclear magnetic resonance imaging

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K072237

Affected lot / code info

Model number 10276755

Why it was recalled

On some systems the gradient cable connections did not meet firm's specifications after installation

Root cause (FDA determination)

Other

Action the firm took

Siemens Medical Solutions USA, Inc sent customers a letter on January 10, 2011 notifying them of an Update Instruction and informing them that recalling firm would preventatively check the gradient cable connections of all systems. For questions regarding this recall call 610-219-6300.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide Distribution including AK, AZ, CA, CT, FL, HI, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NV, OH, OK, OR, PA, RI, TN, TX, VA, WI, and WV

Timeline

Recall initiated

2011-01-10

Posted by FDA

2011-02-23

Terminated

2012-09-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #97383. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.