Shenyang, China
NEUSOFT MEDICAL SYSTEMS IMP & EX recalls
1 recall recorded since 2018, most recently on 9 January 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 9 January 2019
- Terminated
- 25 August 2022
- 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.
- Distribution
- US Distribution in states of: KS, OK and MA.
- Initiated
- FDA Mandated
- Recall number
- Z-0773-2019
- 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 rota
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.