Recall Z-0773-2019 ยท JAK System, X-Ray, Tomography, Computed
NEUSOFT MEDICAL SYSTEMS IMP & EX
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at
| Date | Jan 9, 2019 |
| Status | Terminated |
| Reason | For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons. |
| Root cause | Software design |
| Action | The firm, Neurosoft Medical Systems Co., Inc., issued a notice to its customers dated 11/26/2018. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: Please plan surview length accurately according the clinical requirement, and not interrupt(abort or skip) scanning during the surview scan if the planning length is over 500mm. The defect will be remedied by updating software. Field Change Order related to software updated will be released to the affected systems in Jan, 2019. The affected systems will be upgraded with updated so |
| Quantity | 3 |
| Distribution | US Distribution in states of: KS, OK and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151383 | NeuViz 128 Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd., Nov 4, 2015 |