FDA Device recall Z-1126-2013
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Va…
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Va… by Accuray, citing A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1126-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-19 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Accuray |
| Distribution | US |
Product
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
Reason
A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
Identifiers
| code_info | All units of these models. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Accuray
- Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
FDA Device · Class II · 2026-07-08 · Accuray - Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
FDA Device · Class II · 2026-07-08 · Accuray - CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System
FDA Device · Class II · 2025-02-05 · Accuray - Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System
FDA Device · Class II · 2023-09-06 · Accuray - CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for l…
FDA Device · Class II · 2021-03-24 · Accuray
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1126-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.