FDA Medical Device Recalls (openFDA)
Accuray Incorporated: 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.
- Recall number
- Z-1126-2013
- Recalling firm
- Accuray Incorporated
- 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.
- Status
- Terminated
- Initiated
- 2013-03-19
- Posted
- 2013-04-16
- Terminated
- 2013-10-23
- 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.
- Root cause
- Component design/selection
- Action
- On 3/19/13, an "Urgent Device Correction Letter" was distributed to all affected users, with a description of the problem and user corrective action steps. US customers can contact 1-877- 668-8667 if questions.
- Quantity
- 176 units
- Distribution
- Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.
- Lot, serial or model codes
- All units of these models.
- 510(k) numbers
- ["K122137"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1000123585
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28