—#27286

Product

MR Systems

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K003628, K020991
Affected lot / code info: Upgrade Harmony Syngo MR, model 7106714 K2200 Serial # 10501 through 10587. Harmony Syngo MR, model 7104693 K2200 Serial # 11001 through 11172. Upgrade Symphony Syngo MR, model 7106557 K 2210 Serial # 14001 through 14321. IMPACT - Upgrade Syngo MR (MU3S), model 5751438 K2220 Serial # 15001 through 15030. IMPACT - Upgrade Syngo MR (MU3L), model 7106466 K2220 Serial # 15501 through 15519. VISION - Upgrade Quantum, model 4772971 K2230 Serial # 16001 through 16017. VISION - Upgrade Sonata, model 7388148 K2230 Serial # 16501 through 16513. Concerto Upgrade, model 7106995 K2221 Serial # 17201 through 17211. Concerto, model 4772906 K2221 Serial #17301 through 17473. Syngo Allegra, model 7106433 K2183 Serial #20101 through 20110. Upgrade Allegra syngo MR, model 7387736 K2183 Serial # 20401 through 20421. Trio (Bruker), model 7106441 K2180 Serial #20500 through 20507. Trio, model 7387074 K2180 Serial #20510 through 20524 and 20550 through 20552. Sonata Syngo MR, model 7104719 K2240 Serial #21101 through 21248. Syngo MR SYM-Sonata-Upgrade, model 7104735 K2240 Serial #21604 through 21612. Syngo MR Upgrade Sonata, model 7106425 K2240 Serial #21901 through 21942. Symphony syngo MR, model 7104594 K2210 Serial 22001 through 22996. Rhapsody, model 7384568 K2190 Serial #24001 through 24004.

Why it was recalled

software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.

Timeline

Recall initiated: 2003-02-28
Posted by FDA: 2003-08-07
Terminated: 2004-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27286. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.