FDA recall Z-1747-2019

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.

Reason for recall

GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

Distribution

Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2019-02-12

Report date

2019-06-26

Voluntary/Mandated

FDA Mandated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1747-2019