Recall Z-2056-2008 ยท IYE Accelerator, Linear, Medical
Accuray Inc
CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.
| Date | Sep 17, 2008 (initiated Apr 9, 2008) |
| Status | Terminated |
| Reason | Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users. |
| Root cause | Software design |
| Action | On April 16, 2008, the firm issued notifications via fedex to affected sites. In addition, installation and upgrade procedures will be updated to incorporate a step which decommissions sample beam data. If you have questions, contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or send and email to customersupport@accuray.com. |
| Quantity | 109 units |
| Distribution | Product was distributed to 104 medical centers throughout the US and to Vietnam, China, Korea, Taiwan, Malaysia, Turkey, France, Italy, Spain, Greece and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated, Sep 21, 2007 |