EPIONE 30-0001 v1.0.2Recalls & reported problems
Quantum Surgical · The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K223758); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- May 23, 2025Class IIOpen, Classified
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Z-1927-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223758. One submission often covers many models, so check the product and lot details in each record.
- Z-0037-2025 · Aug 5, 2024 · CompletedThe EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in ver
Other System, X-Ray, Tomography, Computed devices
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
- Revolution Apex EliteGE Medical Systems, L.L.C. · System, x-ray, tomography, computed8 recalls0 reports
- Brilliance CT Big BorePhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed7 recalls1 report
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 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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