RobotRisk Autonomous Systems Incident & Risk Register
RobotRisk / Think Surgical / 2018-03-30
medical robotics · recall

FDA Class II recall: Think Surgical Cutter, Flat, ¿6.2mm x 144mm.

S3 · 03/30
2018 · Think Surgical

Record

CompanyThink Surgical
Categorymedical robotics
Typerecall
Date03/30
2018
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleThink Surgical Cutter, Flat, ¿6.2mm x 144mm.
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceopenFDA enforcement

What happened

FDA enforcement record (Class II, recall Z-2605-2018): There is a potential for the cutter head to detach from the cutter shaft.

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