Recalls / —

—#31101

Product

Magnetom Trio System. Nuclear Magnetic Resonance Imaging Diagnostic Device

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K013586

Affected lot / code info

Model #7387074 - Serial #''s: 20501 through 20508, 20510 through 20524, and 20550 through 20570. Model #7106441 - Serial # 20500

Why it was recalled

tissue roll can become magnetic

Root cause (FDA determination)

Other

Action the firm took

The recalling firm has issued Updated Instructions to replace the stainless steel tissue roll holder. The recalling firm''s representatives are visiting each account to replace the tissue roll holder.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

The product was shipped to medical facilities in CA, CT, DC, FL, GA, IL, IN, KS, KY, MA, MD, MN, NC, NY, OH, OR, PA, TX, and UT.

Timeline

Recall initiated

2003-12-18

Posted by FDA

2004-02-10

Terminated

2004-11-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #31101. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.