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.
Enforcement
- Recall Number
- Z-0012-2018
- Event ID
- 78166
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Toshiba American Medical Systems Inc
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- October 25, 2017
- Initiation Date
- September 12, 2017
- Classification Date
- October 17, 2017
- Termination Date
- November 18, 2020
- Address
- PO Box 2068, 2441 Michelle Dr, Tustin, CA, 92780-7047, United States
Description
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.
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.
Model: HDR-08A
USA (nationwide) Distribution
US - 96