FDA recall Z-2472-2020

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

Product

uCT 530 Computed Tomography X-Ray System

Reason for recall

Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

Distribution

Distributed to Texas.

Key facts

Status
Ongoing
Initiation date
2020-05-08
Report date
2020-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Shanghai, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2472-2020