Recalls / —

—#49380

Product

Magnetom Trio TIM, magnetic resonance imaging

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K050200

Affected lot / code info

Model number 10018221. Serial numbers 35114, 35115, and 35177. Model number 10018222. Serial numbers 35025, 35006, 35022, 35008, 35014, and 35019.

Why it was recalled

Possible excessive RF exposure/may burn

Root cause (FDA determination)

Other

Action the firm took

The recalling firm has issued a Customer Safety Advisory to affected customers per Update Instructions MR038/06/S. The letter informs customers of the potential issue and instructs them not to use the involved coils until this issue can be corrected.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2006-10-12

Posted by FDA

2006-11-29

Terminated

2008-04-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #49380. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.