RobotRisk / Accuray / 2021-02-26

medical robotics · recall

FDA Class II recall: CyberKnife Treatment Delivery System - Product Usage: indicated for im

S3 · 02/26
2021 · Accuray

Record

Company	Accuray
Category	medical robotics
Type	recall
Date	02/26 2021
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	S3 (recall, enforcement, or fleet-wide fault)
Scale	CyberKnife Treatment Delivery System - Product Usage: indica
Confidence	high
Verification	Yes - adversarially checked against the cited source
Source	openFDA enforcement

What happened

FDA enforcement record (Class II, recall Z-1272-2021): The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.

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Accuray vs medical robotics alternatives

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Comparable recall events in medical robotics

Sev	Date	Company	Event
S2	2026-06-09	CMR Surgical	Class II recall of Versius surgeon console over disabled Secure Boot cybersecurity control
S4	2026-03-25	Omnicell	FDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S5	2026-03-11	Intuitive Surgical	Class I recall of da Vinci SureForm stapler reloads after patient death
S3	2026-01-21	Auris Health (J&J MedTech)	FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S3	2025-09-12	Noah Medical	FDA Class II recall: Brand Name: Galaxy System
S3	2025-05-23	Quantum Surgical	FDA Class II recall: EPIONE Model 30-0001
S3	2025-04-23	Virtual Incision	FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S3	2025-02-26	Intuitive Surgical	Class II recall of da Vinci 5 foot pedal over spring failure

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