Agency classClass IIOur severity:High FDA (Devices)·Z-1696-2019·Announced 2019-06-12

Accuray Recalls CyberKnife M6 Systems Due to Collimator Housing Drop Risk

Accuray is recalling 68 CyberKnife M6 systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Accuray Incorporated is recalling 68 units of the CyberKnife M6 Treatment Delivery System, including various configurations such as the M6 FI, FM, FIM, and FI+ systems. The affected units are distributed in the United States and several international locations, including Italy, the United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, the Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, the United Arab Emirates, and Thailand.

The recall is due to a potential unintended drop of the secondary collimator housing. This can occur during automated housing Xchange workflows if an interlock interrupts the operation, causing the housing to only partially attach. The source text does not report any injuries or illnesses associated with this defect.

Healthcare facilities should contact Accuray Incorporated for instructions on how to address this issue. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010…
Manufacturer: Accuray Incorporated
Category: Medical Device — Radiation Therapy System
Hazard: falling-object
equipment-malfunction
Affected units: 68

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

a) 0660000: CyberKnife Treatment Delivery System Serial Numbers: C0434
C0436
C0437
C0438
C0440
C0441
C0443
C0444
C0445
C0446
C0447
C0448
C0449
C0450
C0453
C0454
C0456
C0457
C0458
C0460

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Accuray Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Accuray Incorporated

See all →

Severe
Cyberknife Treatment Delivery System Collimator Docking Failure Risk
FDA (Devices) · 2026-07-08
Severe
Cyberknife Treatment Delivery System Collimator Docking and Fall Hazard Recall
FDA (Devices) · 2026-07-08
High
CyberKnife Treatment System: Internal Snap Ring Detachment Risk
FDA (Devices) · 2025-02-05
High
Upper roller bracket for Radixact gantry enclosure may lack adequate service clearance
FDA (Devices) · 2023-09-06
High
Accuray CyberKnife Treatment Delivery System Recalled for Loose Set Screws
FDA (Devices) · 2021-03-24

Same hazard · falling object