Recalls / —
—#173421
Product
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 product code
- KPS — System, Tomography, Computed, Emission
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K161574
- Affected lot / code info
- Discovery Ml
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 #173421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.