Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
Reported: February 5, 2014 Initiated: January 13, 2014 #Z-0828-2014
Product Description
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
Reason for Recall
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
Details
- Recalling Firm
- Accuray Incorporated
- Units Affected
- 302 devices; 149 in US, 153 out of US.
- Distribution
- Worldwide Distribution. - US (Nationwide) and Mexico; and Internationally to: Australia, Belgium, Canada, China, Colombia, Czech Republic, England, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Malaysia, Luxembourg, Netherlands, Poland, Russia, Saudia Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.. Recalled by Accuray Incorporated. Units affected: 302 devices; 149 in US, 153 out of US..
Why was this product recalled? ▼
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0828-2014.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11