Recall Z-1650-2016— Neusoft Medical Systems Co., Ltd.

Name: FDA recall Z-1650-2016
Creator: U.S. Food and Drug Administration
Published: 2015-05-02

Class II · Terminated

Class II FDA medical device recall by Neusoft Medical Systems Co., Ltd., initiated 2015-05-02, terminated 2016-11-04. It names one FDA 510(k) clearance: K121792. Product: NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i). Reason: It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options..

Recalling firm: Neusoft Medical Systems Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2015-05-02
Terminated: 2016-11-04
Firm location: Shenyang, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K121792 — NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd.·cleared 2012-11-16

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 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)

Reason for recall

It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.

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