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Open, Classified

Discovery PET/CT 710 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-1746-2019 · 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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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