Home / Recalls / Neusoft Medical Systems Co., Ltd. / Z-3044-2017

Z-3044-2017 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
September 6, 2017
Initiation Date
May 19, 2017
Termination Date
November 19, 2020
Voluntary/Mandated
FDA Mandated
Product Quantity
234

Product Description

Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The 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

Software defect

Distribution Pattern

US Nationwide distribution

Code Information

NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version

Other recalls by Neusoft Medical Systems Co., Ltd.

  • 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-1280-2019 Class II — NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Sc (October 22, 2018)
  • Z-3045-2017 Class II — Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi- (May 19, 2017)
  • Z-0875-2017 Class II — NeuViz 64 Multi-slice CT Scanner Systems (August 31, 2016)
  • 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)