Recall Z-1160-2021— Shanghai United Imaging Healthcare Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Shanghai United Imaging Healthcare Co., Ltd., initiated 2021-01-25, terminated 2022-05-03. It names one FDA 510(k) clearance: K181413. 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: 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..
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-25
- Terminated
- 2022-05-03
- Firm location
- Shanghai, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.