Z-1160-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 10, 2021
- Initiation Date
- January 25, 2021
- Termination Date
- May 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
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.
Distribution Pattern
US Nationwide distribution in the state of TX.
Code Information
Serial Number: 270012, 270013, 270014, 270015, 270016, 270017