FDA recall Z-1160-2021

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

Product

Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.

Reason for recall

There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.

Distribution

US Nationwide distribution in the state of TX.

Key facts

Status
Terminated
Initiation date
2021-01-25
Report date
2021-03-10
Termination date
2022-05-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Shanghai, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1160-2021