RegWardenFDA facility compliance records
Company

Quantum Surgical SAS

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2024: 1 recalls; 2025: 1 recalls201720182019202020212022202312024120252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-05-23
    Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
  • Class IICompleted2024-08-05
    Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Quantum Surgical SAS — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10085404-quantum-surgical-sas/

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