Procept BioRobotics
Products: surgical-robot. Risk band: Elevated RobotRisk index 22.4/100 (severity- and time-weighted incidents) · ranked 12 of 25 among Medical robotics companies with incidents (173 tracked).
Analyst brief
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. Procept BioRobotics's index of 22.4 ranks 12 of 25 companies in Medical robotics with incident history. No fire, cyber, or fatality entries appear in the record.
Risk index
Incident timeline
Comparisons over time
Per-type breakdown
| Incident type | Unique incidents | Share |
|---|---|---|
| recall | 2 | 100% |
Unique incident list
2 unique incidents on file for this company.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 09 Jul 2021 | recall | — | FDA Class II recall: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the · AQUABEAM Handpiece, REF: HP2000, a sterile single-use compon | openFDA enforcement |
| S3 | 06 Mar 2019 | recall | — | FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co · AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 32 | openFDA enforcement |
S3 09 Jul 2021 · recall · FDA Class II recall: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the
| Sev | Date | Supporting source row | Source |
|---|---|---|---|
| S3 | 09 Jul 2021 | FDA Class II recall: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the | openFDA enforcement |
S3 06 Mar 2019 · recall · FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co
| Sev | Date | Supporting source row | Source |
|---|---|---|---|
| S3 | 06 Mar 2019 | FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co | openFDA enforcement |
Similar companies
Same industry, nearest RobotRisk band or score.