FDA clears Quantum Surgical Epione robot for abdominal tumor ablation
[REGULATORY ACTION]Mar 26, 2025 · Quantum Surgical · Epione · Leeds, UK
Failure Mode
REGULATORY ACTION
Event Date
Mar 26, 2025
Primary Entity
Quantum Surgical
Robotic Platform
Epione
Jurisdiction / Location
Leeds, UK
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Quantum Surgical's Epione robotic platform received FDA clearance for the abdominal ablation indication. Epione assists physicians in performing percutaneous tumor ablations. The device is also CE marked for abdomen, chest, and musculoskeletal indications. Over 1,400 patients have been treated in Europe and the U.S.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers
https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers
Related Incidents & Failure Precedents
6 records on file- NHTSA opens probe into 1.2 million Tesla Model 3 and Model Y vehicles over front suspension failures[REGULATORY ACTION]
Jul 31, 2026 · Tesla · Tesla Robotaxi (Model Y ADS) · Orlando, Florida, USA
Details - NHTSA grants Zoox temporary exemption to commercially deploy up to 2,500 robotaxis annually[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox clears final federal hurdle, receives NHTSA exemption to launch paid robotaxi service[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details - NHTSA grants Zoox first-ever commercial FMVSS exemption for purpose-built robotaxi[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details - NHTSA launches $5M SAE ITC partnership to develop first-ever AV performance standards and updates AV technical guidance[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details - NHTSA grants Zoox temporary commercial deployment exemption for up to 2,500 robotaxis annually for two years[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details
Incident Context & FAQ
What happened in FDA clears Quantum Surgical Epione robot for abdominal tumor ablation?
Quantum Surgical's Epione robotic platform received FDA clearance for the abdominal ablation indication. Epione assists physicians in performing percutaneous tumor ablations. The device is also CE marked for abdomen, chest, and musculoskeletal indications. Over 1,400 patients have been treated in Europe and the U.S.
When did this incident occur?
The incident is recorded as occurring on March 26, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA clears Quantum Surgical Epione robot for abdominal tumor ablation?
Epione by Quantum Surgical is the recorded robot involved in this incident at Leeds, UK.
Has anyone responded to FDA clears Quantum Surgical Epione robot for abdominal tumor ablation?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA clears Quantum Surgical Epione robot for abdominal tumor ablation?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.