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Class 2 Device Recall Positron Emission Tomography (PET) |
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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
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Product Classification |
System, Tomography, Computed, Emission - Product Code KPS
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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
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For Additional Information Contact |
Maria Ebio 865-218-2534
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = KPS and Original Applicant = CTI PET SYSTEMS, INC.
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