Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray

FDA device recall Z-0776-2019 · posted 2019-02-06 · Open, Classified

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

JAK

Quantity affected

131 units

Distribution

Worldwide Distribution - US (Nationwide Distribution) and countries of: Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco,

Date initiated

2018-07-12

Date posted

2019-02-06

Location

Waukesha, WI

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