PlainRecordsFDA · Medical device recall
Discovery PET/CT 610 Product Usage: The systems are intended for head… and 5 more products
- Date
- June 26, 2019
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- GE Healthcare, LLC
- Reason
- GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
- Distribution pattern
- Nationwide Distribution
6 products in this recall
Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected…
- Product
- Discovery PET/CT 610 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.
- Quantity
- 1113 in total
- Codes and lots
- CT 610
- Recall started
- Feb. 12, 2019
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-1745-2019
Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected…
- Product
- 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.
- Quantity
- 1113 in total
- Codes and lots
- CT 710
- Recall started
- Feb. 12, 2019
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-1746-2019
Optima PET/CT 560…
- 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.
- Quantity
- 1113 in total
- Codes and lots
- CT 560, 560FX
- Recall started
- Feb. 12, 2019
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-1747-2019
Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron…
- Product
- Discovery IQ 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.
- Quantity
- 1113 in total
- Codes and lots
- Discovery IQ
- Recall started
- Feb. 12, 2019
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-1748-2019
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron…
- 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.
- Quantity
- 1113 in total
- Codes and lots
- Discovery Ml
- Recall started
- Feb. 12, 2019
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-1749-2019
Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected…
- Product
- Discovery Ml DR 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.
- Quantity
- 1113 in total
- Codes and lots
- Discovery Ml DR
- Recall started
- Feb. 12, 2019
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-1750-2019
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1745-2019, Z-1746-2019, Z-1747-2019, Z-1748-2019, Z-1749-2019, Z-1750-2019. The agency record governs; check it and the company before acting.