Home / Recalls / Neusoft Medical Systems Co., Ltd. / Z-1650-2016

Z-1650-2016 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
May 18, 2016
Initiation Date
May 2, 2015
Termination Date
November 4, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 units

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.

Distribution Pattern

US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE

Code Information

Serial Numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, N64I140077E

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-0875-2017 Class II — NeuViz 64 Multi-slice CT Scanner Systems (August 31, 2016)