Accuray Inc CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.
Brand
Accuray Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Accuray Inc is recalling CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning So due to 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 b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026