Device Recall Positron Emission Tomography (PET)

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

Radiology Devices

2

No

KS, WA, CA, OH, FL, TX, Germany, Great Britain, Canada Switzerland, Turkey, Argentina, Austria, France, & Spain

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)