FDA recall Z-0446-2021

Shanghai United Imaging Healthcare Co., Ltd. · Class II · 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).

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

US Nationwide distribution including in the state of TX.

Key facts

Status
Ongoing
Initiation date
2020-08-05
Report date
2020-11-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Shanghai, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0446-2021