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RobotRisk › Procept BioRobotics › 06 Mar 2019
Medical robotics · recall

FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co

S3 · 06 Mar 2019 · Procept BioRobotics

Record

CompanyProcept BioRobotics
IndustryMedical robotics
Type(s)recall
Date06 Mar 2019 (day precision)
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
Severity (recall, enforcement, or fleet-wide fault)
ScaleAquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 32
Confidencehigh
Verified flagYes - independently re-checked against the cited source

Summary

FDA enforcement record (Class II, recall Z-1110-2019): Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to compl

Primary source

openFDA enforcement

Publisher: openFDA enforcement · Retrieved: 2026-09-16

Supporting source rows (1)
DateSupporting source rowPublisherLink
06 Mar 2019 FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co openFDA enforcement openFDA enforcement

Procept BioRobotics other incidents timeline

Medical robotics context

recall context

Procept BioRobotics industry position

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