Z-1075-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- July 30, 2019
- Termination Date
- May 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
Product Description
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 Pattern
US Nationwide distribution in the state of TX.
Code Information
DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015