Recalls / —

—#27654

Product

Magnetom Symphony/Sonata, OR Table.

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K012495

Affected lot / code info

Serial Numbers 021107 and 021941.

Why it was recalled

OR Table stops during the transfer of the table to the MR system and will not move.

Root cause (FDA determination)

Other

Action the firm took

Customer Advisory Letter, number 01/2002 titled ''Potential Fault condition of the OR-Table in combination with Magnetom Symphony/Sonata' was sent out to the 2 hospitals in November, 2002.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

CA, TX .

Timeline

Recall initiated

2002-11-27

Posted by FDA

2003-07-03

Terminated

2004-05-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27654. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.