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RobotRisk / Motek Medical / 2019-07-29
medical robotics · recall

FDA Class II recall: Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mil

S3 · 07/29
2019 · Motek Medical

Record

CompanyMotek Medical
Categorymedical robotics
Typerecall
Date07/29
2019
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleBody Weight Support (BWS) Light; Model No. RB011; a componen
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceopenFDA enforcement

What happened

FDA enforcement record (Class II, recall Z-2135-2020): The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.

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