Recall Z-2392-2016 ยท JAK System, X-Ray, Tomography, Computed
Hitachi Medical Systems America Inc
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
| Date | Jun 30, 2015 |
| Status | Terminated |
| Reason | The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient. |
| Root cause | Component design/selection |
| Action | Hitachi sent an Device Correction Notice dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were informed that there is a problem with the Hitachi Medical Systems America, Inc.CT system; the issue is with a power supply in the CT gantry sub-system. During fast rotation (i.e., 35 sec), the centrifugal force applied to the power supply may cause it to fail over time. For further questions, please call (330) 425-1313 ext. 3720. |
| Quantity | 33 units |
| Distribution | US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101888 | SCENARIA WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc., Apr 8, 2011 |