Device Recall MR Systems

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
  • Product Description
    MR Systems
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Parkway, Malvern PA 19355
  • Source
    USFDA