MULTIPURPOSE REMOTE CONTROL R/F SYSTEM DREX-UI80Recalls & reported problems
Canon Inc. · MULTIPURPOSE REMOTE CONTROL R/F SYSTEM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987670100147), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K143281, K170832, K181834); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2025, A NURSE ACCIDENTALLY BUMPED INTO THE C-ARM OF THE DEVICE AND RECEIVED A CUT ON HER FACE BETWEEN HER EYEBROWS. SHE RECEIVED STITCHES AS MEDICAL TREATMENT FOR THE CUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736472 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143281, K170832, K181834. One submission often covers many models, so check the product and lot details in each record.
- Z-2885-2020 · Jul 8, 2020 · Open, ClassifiedSystem Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
- Z-3070-2017 · Mar 15, 2017 · TerminatedToshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography
Other Interventional fluoroscopic x-ray system devices
- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System25 recalls2 deaths3,984 reports
- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths3,614 reports
- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System32 recalls2 deaths2,308 reports
- O-ARM® BI70002000Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system2 recalls1 death3,667 reports
- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System28 recalls1 death2,176 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths2,015 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System20 recalls2 deaths1,837 reports
- Azurion Azurion 7 M12Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System24 recalls2 deaths1,087 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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