Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron
FDA device recall Z-1747-2019 · posted 2019-06-19 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
- Action taken
- 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
- Status
- Open, Classified
- Product code
- KPS
- Quantity affected
- 1113 in total
- Distribution
- Nationwide Distribution
- Date initiated
- 2019-02-12
- Date posted
- 2019-06-19
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIMA PET/CT 560 (K081496) | Ge Medical Systems, LLC | 2008-06-12 |