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U.S. Department of Health and Human Services

Class 2 Device Recall mobile system PET scanner

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  Class 2 Device Recall mobile system PET scanner see related information
Date Initiated by Firm April 05, 2005
Date Posted May 11, 2005
Recall Status1 Terminated 3 on September 11, 2009
Recall Number Z-0819-05
Recall Event ID 31770
510(K)Number K962797  K002584  K003241  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions
ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc.
Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America
Code Information Model Number: 3600079-00 Serial numbers: 0001013, 0001014  Model Number: 3600088-00 Serial numbers: 0001010, 0001016, 0001017, 0001019, 0001021, 0001023, 0001027, 0001029, 0001030, 0001031, 0001038, 0001041, 0001048, 0001051, 0001053, 0001054  Model Number: 3600097-00 Serial numbers: 0101004, 0101019, 0101025, 0101033, 0201041, 0201049, 0201053, 0201063  Model Number: 3600211-00 Serial numbers: 0101007, 0101016, 0101018, 0201023, 0201048, 0201050, 0201058, 0201064, 0201072, 0301082,   Marketed under Siemens Model Number: 3600211-00 0101002, 0101004, 0101015, 0101014, 0101020, 0101021, 0201029, 0201028, 0201035, 0201062, 0201059, 0201063, 0201070, 0301110  Model Number: 3600079-00 Serial numbers: 0001010, 0001011, 0001018  Model Number: 3600085-00 Serial numbers: 0001001, 0001002  Model Number: 3600088-00 Serial numbers: 0001003, 0001006, 0001020, 0001035, 0001036, 0001043, 0001045, 0001044, 0001056, 0001062  Model Number: 3600097-00 Serial numbers: 0101016, 0101018, 0101030, 0201036, 0201040, 0201060  Model Number: 3600211-00 Serial numbers: 0201033, 0201034, 0201067, 0301108  Model Number: 3600099-00 Serial numbers: 0301024  Model Number: 3600088-00 Serial numbers: 001058  Model Number: 3600097-00 Serial numbers: 0101034, 0201038, 0201061 
Recalling Firm/
Manufacturer		 CTI PET Systems Inc
810 Innovation Drive
Knoxville TN 37932-2571
For Additional Information Contact Richard Powers
865-218-2505
Manufacturer Reason
for Recall		 Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.
FDA Determined
Cause 2		 Other
Action Written notification via certified US Mail was sent out beginning 04/05/2005 to distributors and end users (with whom CTI had a service contract) to advise them of the problem.
Quantity in Commerce 80 units
Distribution Nationwide, Canada, the Netherlands, Ireland & Denmark
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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