Discovery Ml 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.
FDA Recall Z-1749-2019 · Posted 2019-06-19
Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeKPS
Date Initiated2019-02-12
Product Quantity1113 in total
Reason for Recall
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.