FDA recall Z-2522-2020

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

Product

uCT 760 System, Computed Tomography X-ray System

Reason for recall

Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.

Distribution

Distributed to two customers. Both customers located in Houston, Texas.

Key facts

Status
Terminated
Initiation date
2020-05-08
Report date
2020-07-15
Termination date
2022-01-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Shanghai, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2522-2020