Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended Recalled by Toshiba American Medical Systems Inc Due to During an examination images were displayed on the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Toshiba American Medical Systems Inc directly.
Affected Products
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.
Quantity: US - 96
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Toshiba American Medical Systems Inc
Toshiba American Medical Systems Inc has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report