Z-0012-2018 Class II Terminated
FDA device recall Z-0012-2018 was initiated by Toshiba American Medical Systems Inc on September 12, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated November 18, 2020). Affected quantity: US - 96.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2017
- Initiation Date
- September 12, 2017
- Termination Date
- November 18, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- US - 96
Product 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.
Reason for Recall
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.
Distribution Pattern
USA (nationwide) Distribution
Code Information
Model: HDR-08A