—#45113

Product

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)

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K003241, K940478
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA Inc
Address: 810 Innovation Dr, Knoxville, Tennessee 37932-2562

Distribution

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

Timeline

Recall initiated: 2006-03-28
Posted by FDA: 2006-04-04
Terminated: 2009-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45113. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.