Recall Z-0908-2011
Accuray Inc · initiated March 16, 2009
Product
CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA A Radiation therapy device.
Codes / lots: All units of these models.
Reason for recall
The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.
FDA-determined cause: Device Design
Action taken
Accuracy Inc., sent an URGENT ADVISORY NOTIFICATION letter, dated March 16, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their system to see if it was affected. Customers were instructed to contact Accuracy Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 or e-mail customersupport@accuracy.com to schedule service.
Details
- Recall number
- Z-0908-2011
- Initiated
- March 16, 2009
- Posted by FDA
- January 18, 2011
- Terminated
- January 19, 2011
- Product code
- IYE – Accelerator, Linear, Medical
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan
- Recalling firm
- Accuray Inc, Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0909-2011 | CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System)…The product has the potential for the extension coupling of the Synchrony extension mounting hardware to… | 03/16/2009Terminated |