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)
Hazard
There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan.
What You Should Do
Remedy
Written notification was sent out beginning 03/28/2006 to end users to advise them of the problem. The notification also included specific work instructions to aid the end user until the patch is available and the upgrade could be performed by a service representative.
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Products
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 Hitac
- Brand
- Siemens Medical Solutions USA Inc
- UPC
- 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
Units Affected
57 devices