Procept BioRobotics
Robot types: Surgical robot. Risk band: Elevated RobotRisk index 22.1/100 (severity- and time-weighted incidents) · ranked 12 of 25 among Medical robotics companies with incidents (274 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. No fire, cyber, or fatality entries appear in the record.
Risk index
Products and robot types
Industries: Medical robotics · Sectors: Hospitals and Health Care
Risk is scored per product and robot type: each incident is attributed to the product it names, or to the company's matching robot type.
| Robot type | Share of company risk | Rank within type |
|---|---|---|
| Surgical robot | 100% | 3 of 8 |
| Product | Robot type | Status | Incidents | Index |
|---|---|---|---|---|
| AquaBeam | Surgical robot | shipping | 2 | 22.1 |
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.