Products: surgical-robot. Risk band: Low RobotRisk index 13.5/100 (incidents/exposure, time-weighted) · 92th percentile of 162 medical robotics companies.
The record contains two entries, both FDA Class II recalls of the AQUABEAM/AquaBeam Handpiece, a sterile single-use component of the company's surgical system, dated 2019 and 2021, each rated severity 3. Both events are regulator-driven recalls of the same device component rather than reported injury or malfunction events, indicating a recurring quality issue with this specific single-use part across a two-year span. The index of 13.6 and 91.9 percentile place Procept in the low band within medical robotics, consistent with recall-level rather than injury- or fatality-level severity. No fire, cyber, or fatality entries appear in the record.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 07/09 2021 |
recall | — | FDA Class II recall: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the · AQUABEAM Handpiece, REF: HP2000, a ste… | openFDA enforcement |
| S3 | 03/06 2019 |
recall | — | FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co · AquaBeam Handpiece, Sterile EO, Rx Onl… | openFDA enforcement |