Recall Z-1165-2013— Philips And Neusoft Medical Systems Co., Ltd.

Name: FDA recall Z-1165-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-04

Class II · Terminated

Class II FDA medical device recall by Philips And Neusoft Medical Systems Co., Ltd., initiated 2013-03-04, terminated 2013-11-22. It names 2 FDA 510(k) clearances: K092742, K090173. Product: NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 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 with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Reason: User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel..

Recalling firm: Philips And Neusoft Medical Systems Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2013-03-04
Terminated: 2013-11-22
Firm location: Shenyang, Liaoning, China

510(k) clearances named in this recall

2 on FDA's record

K092742 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd.·cleared 2009-09-22
K090173 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd.·cleared 2009-02-05

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 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 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 with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients

Reason for recall

User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.

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