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U.S. Department of Health and Human Services

Class 2 Device Recall Positron Emission Tomography (PET)

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  Class 2 Device Recall Positron Emission Tomography (PET) see related information
Date Initiated by Firm March 28, 2006
Date Posted April 04, 2006
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-0712-06
Recall Event ID 35001
510(K)Number K003241  K940478  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
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)
Code Information 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 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA Inc
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information Contact Maria Ebio
865-218-2534
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 57 devices
Distribution KS, WA, CA, OH, FL, TX, Germany, Great Britain, Canada Switzerland, Turkey, Argentina, Austria, France, & Spain
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = CTI PET SYSTEMS, INC.
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