CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is i
FDA device recall Z-0865-2017 · posted 2016-12-21 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife Robotic Radiosurgery System.
- Action taken
- Accuray Incorporated sent an Urgent Safety Advisory Notification letter to all affected customers on December 1, 2016 by traceable method.. Letters identified the product, the problem, and the action to be taken by the customer. provided users with affected product and described the issue. The final resolution will result in a modulator cabinet inspection and installation of the Plexiglas cover - as necessary. Customers will be contacted by Accuray to schedule the inspection. Prior to this modulator cabinet inspection, inform all applicable personnel of the potential danger and need to closely follow electrical safety procedures. Customers with questions were instructed to contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Tehnical Solution Center at http://www.accuray.com/services-support or call: North America +1-877-666-8667, Europe +800-4141-9595, Hong Kong +852-2247-8688, Japan +81-3-6265-1530. Customers were also asked to complete the attached acknowledgement and return to Accuracy. For questions regarding this recall call 608-824-3362.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 115 affected devices.
- Distribution
- Worldwide Distribution - US including CA. MN, OK. FL. MO, TN, KS, TX, AZ, MS, IA, MA. NC, NY. IN, NJ, VA. LA, WA, WI, PA. CT, G,. MT, MD, LA., WV, OH, and DC. Foreign distribution to Taiwan, Japan, Ko
- Date initiated
- 2016-12-06
- Date posted
- 2016-12-21
- Date terminated
- 2017-06-09
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE SYSTEM (K011024) | Accuray, Inc. | 2001-08-10 |