FDA recall Z-0858-2021

Product

Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Reason for recall

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Distribution

Worldwide

Key facts

Status

Ongoing

Initiation date

2020-12-10

Report date

2021-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0858-2021