FDAClass II · Medical device · Recall Z-2644-2026 · Recalled July 8, 2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall — Accuray Incorporated
Agency report date: July 8, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: 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.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
Other medical device recalls from around the same time
- Abiomed REF recall — Oscor Inc.FDA · July 22, 2026
- Abiomed REF recall — Oscor Inc.FDA · July 22, 2026
- Medtronic Harmony Delivery Catheter System recall — Medtronic Heart Valves DivisionFDA · July 8, 2026
- A M S recall — Windstone Medical Packaging, Inc.FDA · July 8, 2026
- A M S recall — Windstone Medical Packaging, Inc.FDA · July 8, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 6, 2026 at 6:00 PM UTC.