Recall Z-0776-2019 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
| Date | Feb 6, 2019 (initiated Jul 12, 2018) |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| Action | 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 th |
| Quantity | 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, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, Unite |
| FDA record | Open on fda.gov |