|
Class 2 Device Recall mobile system PET scanner |
|
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.
|
|
|
|