Device product
Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - 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).
Z-0446-2021
Product summary
- Event
- Event 86269
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0446-2021
Official wording
Reason: 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.
Code information: Serial Numbers: 353020, 353021, 353023, 353045, 353049
Distribution pattern: US Nationwide distribution including in the state of TX.
Derived failure modes
-
Unknown
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.