Recalls / —

—#51474

Product

Magnetom Espree System with OR Table

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K041112

Affected lot / code info

Model number 10092082, serial number 1002, 1003, and 1004.

Why it was recalled

If table top is not seated properly it can lock up/stick.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a Safety Advisory Letter to their customers on March 30, 2007, informing them of the problem and steps to take to avoid the problem.

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 NY and TX.

Timeline

Recall initiated

2007-03-30

Posted by FDA

2007-04-26

Terminated

2007-08-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #51474. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.