Revolution EVO…

Date

July 7, 2021

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

GE Healthcare, LLC

Product

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

Reason

Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

Distribution pattern

3,665 (US = 956; OUS = 2,709)

Quantity

3665

Codes and lots

Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2

Recall started

June 14, 2021

Device type

System, X-Ray, Tomography, Computed

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

GE Healthcare will send an Important Electronic Product Radiation Warning letter to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take to prevent this issue.

Recall number

Z-1900-2021

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1900-2021. The agency record governs; check it and the company before acting.