Quantum Surgical recalls EPIONE Model 30-0001 with UDI-DI code 03760305400031 due to a software bug that may cause the robotic arm to guide instruments incorrectly compared to user planning. Affected units include specific serial numbers and software version 1.0.6.1.
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Quantum Surgical is recalling the EPIONE Model 30-0001 robotic accessory because a software bug could cause it to guide surgical instruments incorrectly compared to the user's planned positioning. This may lead to inaccurate procedures during CT-guided ablation surgeries.
The software bug causes the robotic arm to guide surgical instruments differently than what the user planned during the procedure. This could result in inaccurate placement of instruments during CT-guided ablation surgeries, potentially affecting treatment outcomes.
Physicians performing CT-guided percutaneous ablation procedures in the abdomen using the EPIONE device are most at risk. The recall affects specific units with serial numbers 0322002, 0323006, 0323003, and 0324001.
Check if your EPIONE device has the model number 30-0001 and UDI-DI code 03760305400031. The affected units include specific serial numbers: 0322002, 0323006, 0323003, and 0324001, and software version 1.0.6.1.
Verify your EPIONE device's model number, UDI-DI code, and serial number to confirm if it's affected.
Reach out to Quantum Surgical for further instructions on how to address the software issue.
The affected units have software version 1.0.6.1.
Serial numbers 0322002, 0323006, 0323003, and 0324001 are affected.
The software bug may cause the robotic arm to guide surgical instruments incorrectly compared to the user's planned positioning, potentially leading to inaccurate procedures.
We’ve drafted a message you can send Quantum Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1927-2025 — Quantum Surgical Quantum Surgical Hello, I own a Quantum Surgical that is covered by recall Z-1927-2025 from Quantum Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
