PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: June 26, 2019 Initiated: February 12, 2019 #Z-1750-2019

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

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
1113 in total
Distribution
Nationwide Distribution
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
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.. Recalled by GE Healthcare, LLC. Units affected: 1113 in total.
Why was this product recalled?
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Which agency issued this recall?
This recall was issued by the FDA Devices on June 26, 2019. Severity: Moderate. Recall number: Z-1750-2019.