—#30294

Product

Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K020991
Affected lot / code info: Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and 7106557.

Why it was recalled

Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm field representatives are visiting each location to correct the problem through a software upgrade.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: The products were shipped nationwide to hospitals and medical imagining centers.

Timeline

Recall initiated: 2003-10-16
Posted by FDA: 2003-12-03
Terminated: 2004-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30294. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.