The Recall Desk
HighFDA (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.

What this means for you

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: Cyb
Manufacturer
Accuray Incorporated
Category
Medical Device — Radiation Therapy System
Hazard
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 →

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