FDA recall Z-1075-2022

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

Product

Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

Reason for recall

X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.

Distribution

US Nationwide distribution in the state of TX.

Key facts

Status: Terminated
Initiation date: 2019-07-30
Report date: 2022-05-18
Termination date: 2022-05-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Shanghai, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1075-2022