Z-1750-2019 Class II Ongoing
FDA device recall Z-1750-2019 was initiated by GE Healthcare, LLC on February 12, 2019 and is designated Class II. Reason for recall: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure The recall status is ongoing. Affected quantity: 1113 in total.
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- February 12, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 1113 in total
Product Description
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.
Reason for Recall
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Distribution Pattern
Nationwide Distribution
Code Information
Discovery Ml DR