Accuray Cyberknife Treatment Deliver 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 48 Cyberknife Treatment Deliver 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 8, 2026 and geographically references United States. 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-device.
What Happened
Accuray Incorporated is recalling the Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer because in certain cases a collimator may not fully dock. This 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 Products Are Affected
The recall covers the Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator. It affects 48 units distributed worldwide, including US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, and Ukraine. The recall applies to all systems prior with software version 11X that utilize the Exchange Table. Recall number Z-2640-2026. Classification: Class II.
What You Should Do
No specific consumer action steps are provided in the recall notice.
Why This Matters
The recall involves medical devices distributed across the United States and multiple international markets.
Source
FDA recall Z-2640-2026, Accuray Incorporated, Madison, WI.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
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 (1,276 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.