Z-0875-2017 Class II Terminated
FDA device recall Z-0875-2017 was initiated by Neusoft Medical Systems Co., Ltd. on August 31, 2016 and is designated Class II. 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 restar… The recall status is terminated (terminated January 4, 2018). Affected quantity: 23 units.
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