CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.
This recall has been terminated (originally issued September 17, 2008).
- Company
- Accuray Inc
- Recall Initiated
- April 9, 2008
- Posted
- September 17, 2008
- Terminated
- November 30, 2010
- Recall Number
- Z-2056-2008
- Quantity
- 109 units
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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
Root 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.