Recall Z-0876-2017— Neusoft Medical Systems Co., Ltd.

Name: FDA recall Z-0876-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-31

Class II · Terminated

Class II FDA medical device recall by Neusoft Medical Systems Co., Ltd., initiated 2016-08-31, terminated 2018-01-04. It names one FDA 510(k) clearance: K121792. Product: NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version. Reason: The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume..

Recalling firm: Neusoft Medical Systems Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-08-31
Terminated: 2018-01-04
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 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

Reason for recall

The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.

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