FDA Medical Device Recalls (openFDA)
Accuray Inc: RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
- Recall number
- Z-0853-2011
- Recalling firm
- Accuray Inc
- Product
- RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
- Status
- Terminated
- Initiated
- 2009-07-21
- Posted
- 2011-01-11
- Terminated
- 2011-01-12
- Reason
- Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
- Root cause
- Device Design
- Action
- Consignees were notified verbally about the issue when an inspection was scheduled.
- Quantity
- 26
- Distribution
- Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland.
- Lot, serial or model codes
- RoboCouch model 025007
- 510(k) numbers
- ["K042146","K072504"]
- PMA numbers
- not on file
- Product code
- JAI
- 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