Z-2056-2008

CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software...

Name: Z-2056-2008 CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software...
Creator: Accuray Inc
Published: 2008-04-09
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2008-04-09 / Terminated / root cause: software

FDA source

Accuray Inc began a recall of CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher on 2008-04-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2056-2008
Status: Terminated
Initiated: 2008-04-09
Posted: 2008-09-17
Terminated: 2010-11-30
Recalling firm: Accuray Incorporated
Product: CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA 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 [email protected].
Quantity in commerce: 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.
Product codes and 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

Product code IYE

K072504Class IICyberknife Robotic Radiosurgery SystemAccuray Incorporated / cleared 2007-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)