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U.S. Department of Health and Human Services

Class 2 Device Recall Optima PET/CT 560, 560FX

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  Class 2 Device Recall Optima PET/CT 560, 560FX see related information
Date Initiated by Firm February 12, 2019
Date Posted June 19, 2019
Recall Status1 Open3, Classified
Recall Number Z-1747-2019
Recall Event ID 82982
510(K)Number K081496  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Optima PET/CT 560, 560FX

Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission
Tomography (PET) imaging and localization of emission activity in patient anatomy by means of
integrated PET and CT images.
Code Information CT 560, 560FX  
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare sent a notification letter to affected customer (Hospital Administrators/Risk Managers. Managers of Radiology/Cardiology, Radiologist/Cardiologist). The letter identified the affected product, problem and actions to be taken. Customers were informed GE Healthcare will without charge, remedy the defect or bring the product into compliance. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 1113 in total
Distribution Nationwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS, LLC
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