Recall Z-1748-2022 ยท JAK System, X-Ray, Tomography, Computed
FUJIFILM Healthcare Americas Corporation
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
| Date | Jul 12, 2022 |
| Status | Open, Classified |
| Reason | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation |
| Root cause | Under Investigation by firm |
| Action | FujiFilm issued Urgent Medical Device Letter were sent via email on July 12, 2022, consignees without an email contact were notified via FedEx on July 12, 2022 and July 15, 2022. Letter states reason for recall, health risk and action to take: Until your upgrade is scheduled and completed, you can continue to safely use your CT system by following these additional instructions: 1. When entering alphabetic characters in the patient information, please enter them in capital letters (e.g. ready READY ) 2. Set Auto Capital Letter to ON in the Preference Settings window. This will convert a |
| Quantity | 46 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213829 | SCENARIA View Fujifilm Healthcare Corporation, May 23, 2022 |