Recall Z-2056-2008
Accuray Inc · initiated April 9, 2008
Product
CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.
Codes / lots: Versions 1.5.2, with system numbers (all preceded by C0) 095, 142, 058, 106, 061, 056, 128, 129, 079, 088, 116, 151, 139, 047, 070, 072, 133, 112, 149, 078, 137, 025, 098, 092, 045, 144, 124, 160, 044, 126, 123, 111, 055, 062, 074, 068, 059, 052, 103, 132, 100, 150, 051, 094, 119, 034, 146, 153, 064, 155, 037, 114, 046, 063, 097, 143, 067, 131, 042, 048, 090, 091, 122, 159, 022, 109, 099, 135, 036, 134, 127, 158, 057, 069, 030, 118, 108, 152, 136, 049, 102, 080, 101, 141, 071, 087, 140, 107, 145, 148, 120, 023, 147, 089, 038, 041, 065, 138, 060, 113, 110, 130, 043, 125, 105, 093, 117, 032, 066
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-2056-2008
- Initiated
- April 9, 2008
- Posted by FDA
- September 17, 2008
- Terminated
- November 30, 2010
- Product code
- IYE – Accelerator, Linear, Medical
- 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.
- Recalling firm
- Accuray Inc, Sunnyvale, CA