Device product
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Z-1075-2022
Product summary
- Event
- Event 90104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-1075-2022
Official wording
Reason: 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.
Code information: DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
Distribution pattern: US Nationwide distribution in the state of TX.
Derived failure modes
-
Labeling or packaging
incorrectly labeled