FDA Class 2 recall of Epione needle guide component due to rust
[RECALL]Aug 5, 2024 · Quantum Surgical · Epione · Leeds, UK
Failure Mode
RECALL
Event Date
Aug 5, 2024
Primary Entity
Quantum Surgical
Robotic Platform
Epione
Jurisdiction / Location
Leeds, UK
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Quantum Surgical issued an urgent field safety notice for 2 Epione units in Florida after discovering rust on a component (central axis) inside the Needle Guide product (product number 02-0027). The affected units were returned, repaired, and replaced. Recall was completed by October 2024.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=209707
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=209707
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Details
Incident Context & FAQ
What happened in FDA Class 2 recall of Epione needle guide component due to rust?
Quantum Surgical issued an urgent field safety notice for 2 Epione units in Florida after discovering rust on a component (central axis) inside the Needle Guide product (product number 02-0027). The affected units were returned, repaired, and replaced. Recall was completed by October 2024.
When did this incident occur?
The incident is recorded as occurring on August 5, 2024 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 Class 2 recall of Epione needle guide component due to rust?
Epione by Quantum Surgical is the recorded robot involved in this incident at Leeds, UK.
Has anyone responded to FDA Class 2 recall of Epione needle guide component due to rust?
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 Class 2 recall of Epione needle guide component due to rust?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.