Device product
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.
Z-0012-2018
Product summary
- Event
- Event 78166
- Status
- Terminated
- Classification
- Class II
- Quantity
- US - 96
- Official record key
device-enforcement:Z-0012-2018
Official wording
Reason: During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
Code information: Model: HDR-08A
Distribution pattern: USA (nationwide) Distribution
Derived failure modes
-
Unknown
During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.