Recall Z-0773-2019— NEUSOFT MEDICAL SYSTEMS IMP & EX

Name: FDA recall Z-0773-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-09

Class II · Terminated

Class II FDA medical device recall by NEUSOFT MEDICAL SYSTEMS IMP & EX, initiated 2019-01-09, terminated 2022-08-25. It names one FDA 510(k) clearance: K151383. Product: 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 different angles or spiral planes taken at different angles.. 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..

Recalling firm: NEUSOFT MEDICAL SYSTEMS IMP & EX
Classification: Class II
Status: Terminated
Initiated: 2019-01-09
Terminated: 2022-08-25
Firm location: Shenyang, China

510(k) clearances named in this recall

1 on FDA's record

K151383 — NeuViz 128 Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.·cleared 2015-11-04

K-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

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 different angles or spiral planes taken at different angles.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.