Device Recall Positron Emission Tomography (PET)

  • Model / Serial
    software versions 7.2.2 rel 2, 7.2.2 rel 4A, 7.2.2 rel 5 and 7.3 Model: ART Model Number: 3600066-00 Serial numbers: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, 1010, 1012, 1013, 1014  Model: ART Model Number: 3600078-00 Serial numbers: 1001, 1002, 1003  Model: ART Model Number: 3600082-00 Serial numbers: 1002  Model: ART Model Number: 3600084-00 Serial numbers: 1001, 1002, 1003, 1004, 1005, 1006,   Model: ART 2000 Model Number: 3600090-00 Serial numbers: 1001, 1002, 1003, 1004, 201005, 201006  Model: EMERGE, EMERGE (Toshiba), EMERGE (Sceptre - Hitachi), EMERGE m (Sceptre - Hitachi), PICO EMERGE (Sceptre-Hitachi), PICO EMERGEm (Sceptre - Hitachi) Model Number: 3600099-00 Serial numbers: 101001, 201002, 201003, 201004, 201005, 201006, 201007, 201008, 201009, 201010, 201011, 201012, 301013, 301014, 301015, 301016, 301017, 301018, 301019, 301020, 301022, 301023, 301024, 301025, 301026, 301027, 301028  Model Number: PICO EMERGE (Sceptre-Hitachi) Model Number: P008060 Serial number: 401001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    KS, WA, CA, OH, FL, TX, Germany, Great Britain, Canada Switzerland, Turkey, Argentina, Austria, France, & Spain
  • Product Description
    ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA Inc, 810 Innovation Dr, Knoxville TN 37932-2562
  • Source
    USFDA