RobotRisk Autonomous Systems Incident & Risk Register
RobotRisk / Procept BioRobotics / 2019-03-06
medical robotics · recall

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

S3 · 03/06
2019 · Procept BioRobotics

Record

CompanyProcept BioRobotics
Categorymedical robotics
Typerecall
Date03/06
2019
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleAquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 32
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceopenFDA enforcement

What happened

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

Procept BioRobotics record context

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012019 S3: 11192021 S3: 1121
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medical robotics: entries by year

2545082015 S2: 12015 S3: 12152016 S3: 32016 S4: 14162017 S4: 11172018 S2: 12018 S3: 12182019 S3: 33192020 S3: 1052020 S5: 3108202021 S3: 1642021 S4: 12021 S5: 3168212022 S2: 12022 S3: 1352022 S5: 10146222023 S3: 2222023 S5: 2224232024 S3: 2692024 S5: 7276242025 S3: 5042025 S5: 4508252026 S1: 12026 S2: 12026 S3: 4262026 S4: 52026 S5: 844126
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medical robotics: failure modes

medical robotics: most entries

recall context

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recall: by year

recall: severity profile

Comparable recall events in medical robotics

SevDateCompanyEvent
S22026-06-09CMR SurgicalClass II recall of Versius surgeon console over disabled Secure Boot cybersecurity control
S42026-03-25OmnicellFDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S52026-03-11Intuitive SurgicalClass I recall of da Vinci SureForm stapler reloads after patient death
S32026-01-21Auris Health (J&J MedTech)FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S32025-09-12Noah MedicalFDA Class II recall: Brand Name: Galaxy System
S32025-05-23Quantum SurgicalFDA Class II recall: EPIONE Model 30-0001
S32025-04-23Virtual IncisionFDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S32025-02-26Intuitive SurgicalClass II recall of da Vinci 5 foot pedal over spring failure

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