Tos: Toshiba Medical Kalare X-Ray System Recalled for Image Display Failure
Toshiba recalls DREX-KL80 X-ray system due to images not displaying on monitor or saving to hard disk during exams. Affected units may have imaging errors affecting patient care.
Lower-risk 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.
Contact the company
What happened, in plain English
Toshiba is recalling its DREX-KL80 fluoroscopic X-ray system because images don't show up on the monitor or save to the hard drive during exams. This could lead to missed diagnoses or incorrect treatments if the images aren't properly recorded. Read more at govinfonow.com/recall/73036-tos-toshiba-medical-kalare-x-ray-system-recalled-for-image.
Source Summary by GovInfoNow · govinfonow.com/recall/73036-tos-toshiba-medical-kalare-x-ray-system-recalled-for-image · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0012-2018
Cite this page
“Tos: Toshiba Medical Kalare X-Ray System Recalled for Image Display Failure.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73036-tos-toshiba-medical-kalare-x-ray-system-recalled-for-image. Based on FDA recall #Z-0012-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0012-2018%22&limit=1).
Why it’s dangerous
The system fails to display images on the live monitor or save them to the hard disk during examinations. This means doctors or technicians might not have access to the images needed for proper diagnosis or treatment decisions.
Who’s affected
Healthcare providers using the DREX-KL80 system for medical imaging may be affected. Patients undergoing X-rays with this equipment could face potential errors in their imaging records.
How to tell if you have this one
Check for the model number HDR-08A on the system. The DREX-KL80 system was sold for medical use in the U.S. by Toshiba American Medical Systems Inc.
- Brand
Toshiba- Category
Medical device
What to do — step by step
Check System Status
Verify if images display on the live monitor and save to the hard disk during examinations.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA (nationwide) Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0012-2018 (September 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0012-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.