Recall Z-0271-2020 ยท JAK System, X-Ray, Tomography, Computed
Hitachi Medical Systems America Inc
Hitachi Scenaria Whole-body X-ray CT System
| Date | Oct 16, 2019 |
| Status | Terminated |
| Reason | There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Correction Notice dated 10/15/19 was sent to customers. Hitachi will inspect all heat controller units for Scenaria systems S5002-S5014 and S5017-S5044 to ensure that the cables and cable loop clamp are affixed as instructed and apply modifications as needed. We expect to begin this process in late October I early November 2019. This action will be implemented by Hitachi Service at no charge to you. Your Service Area Manager will contact you for scheduling. Please contact me if you need further information regarding this report. You can send any questions, comments |
| Quantity | 39 |
| Distribution | The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR. The products were distributed to the following foreign countries: Brazil and Mexico. |
| FDA record | Open on fda.gov |