Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
This recall is currently active, issued February 6, 2019. It was issued by Ge Healthcare, Llc.
- Company
- Ge Healthcare, Llc
- Recall Initiated
- July 12, 2018
- Posted
- February 6, 2019
- Recall Number
- Z-0776-2019
- Quantity
- 131 units
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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
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, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Lot / Code Info
SmartStep Option
Root Cause
Software design
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.