Recall Z-3045-2017— Neusoft Medical Systems Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Neusoft Medical Systems Co., Ltd., initiated 2017-05-19, terminated 2020-11-19. It names one FDA 510(k) clearance: K151383. Product: Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The 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 different angles or spiral planes taken at different angles.. Reason: Software defect.
- Recalling firm
- Neusoft Medical Systems Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-19
- Terminated
- 2020-11-19
- Firm location
- Shenyang, N/A, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The 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 different angles or spiral planes taken at different angles.
Reason for recall
Software defect
Data sourced from openFDA. This site is unofficial and independent of the FDA.