Recall Z-2839-2018 ยท JAK System, X-Ray, Tomography, Computed
Hitachi Medical Systems America Inc
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA can be post processed by the SCENARIA to provide additional information. Post processing cap
| Date | Jun 29, 2018 |
| Status | Terminated |
| Reason | The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The problem could not be duplicated at the site, so to avoid further issues while a root cause investigation was pursued, Hitachi choose to add an optional touch sensor to the gantry to add a redundant level of protection. It is conceivable that a patient s extremity may be caught between the tabletop and the gantry surface during uncontrolled motion or that the table contact of the gantr |
| Root cause | Nonconforming Material/Component |
| Action | On 6/19/18, the firm was notified of the problem at a customer site. The firm is currently investigating the underlying cause to formulate a planned corrective action. On 6/29/18, the firm took a preventive measure at the site which originated the complaint: Hitachi added an optional touch sensor to the unit to lessen the chance of injury. The firm may take additional corrective action on other units distributed to customers once root cause investigation is complete. |
| Quantity | 1 |
| Distribution | US Distribution to one customer in TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150595 | SCENARIA Phase 3 Whole-body X-ray CT System Hitachi Medical Systems America, Inc., Oct 30, 2015 |