CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
Cyberknife Treatment Deliver System equipped recalled
Accuray is recalling Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer, distributed nationwide in the US. The recall was initiated on 16 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2644-2026
- FDA event ID
- 99083
- Recalling firm
- Accuray, Madison, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jun 2026
- FDA classified
- 1 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Masks, Gloves & PPE
Timeline
| 16 Jun 2026 | Recall initiated by company | |
| 1 Jul 2026 | Classified by FDA | +15 days |
| 8 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Where it was distributed
Worldwide - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
Questions about this recall
Why was it recalled?
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Which lots are affected?
ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.
Where was it sold?
Worldwide - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Accuray
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | CyberKnife Treatment Delivery System recalled by Accuray Incorporated | Accuray | Other | Nationwide |
| Device | CLASS II | Upper roller bracket recalled by Accuray Incorporated | Accuray | Device Malfunction | Nationwide |
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Other Masks, Gloves & PPE recalls
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| Device | CLASS II | Opportunity Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Performance Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |