—#173419

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081496
Affected lot / code info: CT 560, 560FX

Why it was recalled

GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2019-02-12
Posted by FDA: 2019-06-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173419. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.