Revolution CT scanners Product Usage: The system is intended for head…

Date

July 24, 2019

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 CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason

Additional low dose radiation exposure.

Distribution pattern

Worldwide - US Nationwide Distribution

Quantity

857 (US = 195: OUS = 662)

Codes and lots

Revolution CT

Recall started

Jan. 19, 2019

Device type

System, X-Ray, Tomography, Computed

Root cause (FDA)

Device Design

What the company told customers

GE Healthcare will send a customer letter that provide safety instructions for immediate mitigation of the issue. The customer can continue to use the system with the recommended workaround instruction provided in the customer letter: All affected systems will be corrected with updated software and a User Manual Addendum which re-emphasizes existing pat ient center ing instructions. If you have any questions or concerns regarding this notification. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-1951-2019

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

Source: FDA · Medical device enforcement report, recall number Z-1951-2019. The agency record governs; check it and the company before acting.