Accuray Cyberknife Treatment Delivery System Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Accuray Incorporated is recalling 292 Cyberknife Treatment Delivery Systems worldwide due to a risk of collimator release and fall.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Accuray Incorporated initiated a voluntary recall after determining that in certain cases, a collimator may not fully dock. This triggers a system interlock preventing 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 Products Are Affected
The recall covers the Cyberknife Treatment Delivery System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator. It affects ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table. A total of 292 units are involved. Distribution is worldwide, including the United States 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, and United Kingdom. The recall number is Z-2644-2026.
What You Should Do
Users of affected systems should follow guidance provided in the firm's notification letter regarding the identified docking issue.
Why This Matters
The recall involves 292 units distributed worldwide and addresses a potential equipment malfunction during treatment procedures.
Source
FDA recall number Z-2644-2026; recalling firm Accuray Incorporated, Madison, WI.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,614 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.