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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, 560FXsee related information
Date Initiated by FirmFebruary 12, 2019
Date PostedJune 19, 2019
Recall Status1 Open3, Classified
Recall NumberZ-1747-2019
Recall Event ID 82982
510(K)NumberK081496 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductOptima 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
ActionGE 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 Commerce1113 in total
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPS
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