Home / Recalls / Neusoft Medical Systems Co., Ltd. / Z-0875-2017

Z-0875-2017 Class II Terminated

Recalled by Neusoft Medical Systems Co., Ltd. — Shenyang, N/A

Recall Details

Product Type
Devices
Report Date
January 4, 2017
Initiation Date
August 31, 2016
Termination Date
January 4, 2018
Voluntary/Mandated
FDA Mandated
Product Quantity
23 units

Product Description

NeuViz 64 Multi-slice CT Scanner Systems

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.

Distribution Pattern

US Distribution

Code Information

NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version. NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 or previous version

Other recalls by Neusoft Medical Systems Co., Ltd.

  • Z-1280-2019 Class II — NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Sc (October 22, 2018)
  • Z-1281-2019 Class II — NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slic (October 22, 2018)
  • Z-1279-2019 Class II — NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Sca (October 22, 2018)
  • Z-3044-2017 Class II — Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz (May 19, 2017)
  • Z-3045-2017 Class II — Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi- (May 19, 2017)
  • Z-0876-2017 Class II — NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 o (August 31, 2016)
  • Z-1650-2016 Class II — NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, Ne (May 2, 2015)