Revolution CT systems with the SmartStep Option The system is intended for head…

Date

Feb. 13, 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 systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason

On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator

Distribution pattern

Worldwide Distribution - US (Nationwide Distribution) and countries of: Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Quantity

131 units

Codes and lots

SmartStep Option

Recall started

July 12, 2018

Device type

System, X-Ray, Tomography, Computed

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent a Notification letter dated October 18, 2018 to affected customers and sent a second letter dated October 30, 2018. The letters identified the affected product, problem and actions to be taken. The customers were instructed to do the following: ensure that all potential users in your facility are made aware of this notification and the recommended action, also stated: To avoid the issue, only use the 'In' button on the gantry controls and follow this required workflow: 1. Move the table back into the gantry using the 'In' button on the gantry controls . 2. Verify that the needle position is aligned using the internal laser alignment light. GE Healthcare will correct both forward production and impacted customer devices with a software update. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-0776-2019

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

Source: FDA · Medical device enforcement report, recall number Z-0776-2019. The agency record governs; check it and the company before acting.