Discovery PET/CT 710 recallZ-1746-2019 · GE Healthcare, LLC · initiated Feb 12, 2019
Class II Open, Classified All recalls posted in June 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
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 details
- Recall number
- Z-1746-2019
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 12, 2019
- Posted by the FDA
- Jun 19, 2019
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 1113 in total
- Product code
- KPS
- FDA submissions
- K133657
- Distribution
- Nationwide Distribution
Product description
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.
Code information (models, lots, serial numbers)
CT 710
Other devices under the same FDA submission
2 devices cleared under K133657 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Discovery MI Digital ReadyGE Medical Systems, L.L.C. · System, tomography, computed, emission1 recall0 reports
- Discovery MI Digital ReadyGE Medical Systems, L.L.C. · System, tomography, computed, emission1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 82982).
- Z-1748-2019 · Open, ClassifiedDiscovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission acti…
- Z-1749-2019 · Open, ClassifiedDiscovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission acti…
- Z-1750-2019 · Open, ClassifiedDiscovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission a…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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