Z-0447-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 18, 2020
- Initiation Date
- August 5, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Reason for Recall
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Distribution Pattern
US Nationwide distribution including in the state of TX.
Code Information
Serial Numbers: 600229, 600230, 600232, 600271, 600282