Revolution CT

Date

July 14, 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

Completed

Filed by

GE Healthcare, LLC

Product

Revolution CT

Reason

GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

Distribution pattern

Worldwide distribution - US Nationwide

Quantity

197 (US = 40; OUS = 157)

Codes and lots

5590000 5590000-6 5590000-2

Recall started

March 19, 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 perform an initial site assessment and replace the collimator, if needed. This will be followed by bi-weekly remote monitoring of the system s log file. Finally, GE Healthcare will install a currently under development software patch, added to the daily fast calibration to automatically and reliably detect this failure should it occur. All of these actions will be performed at no cost to the customer. For questions call 262-544-3217.

Recall number

Z-2004-2021

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

Source: FDA · Medical device enforcement report, recall number Z-2004-2021. The agency record governs; check it and the company before acting.