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RobotRisk / Stryker Mako / 2024-04-15
medical robotics · recall

Class II recall of Mako 3.0/3.1 software over error #3 causing loss of robotic function mid-surgery

S3 · 04/15
2024 · Stryker Mako

Record

CompanyStryker Mako
Categorymedical robotics
Typerecall
Date04/15
2024
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleMako 3.0 and 3.1 software, field correction to installed base
Confidencemedium
VerificationCited source on file; not independently re-verified
SourceMassDevice

What happened

Stryker issued an urgent field safety notice and FDA Class II recall for Mako total knee/hip application software after an increase in software error #3 codes occurring when the system was not shut down/restarted between switching total knee and total hip applications, which could cause loss or deterioration of robotic system function and extended surgery time.

Stryker Mako record context

Entries by year and severity

14292018 S2: 11182020 S3: 1919202021 S3: 2929212022 S2: 12022 S3: 1213222023 S3: 1616232024 S3: 1515242025 S3: 2727252026 S3: 152026 S4: 11626
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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

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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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