Class 2 Device Recall CyberKnife Robotic Radiosurgery System

• Date Initiated by Firm: April 09, 2008
• Date Posted: September 17, 2008
• Recall Status: Terminated on November 30, 2010
• Recall Number: Z-2056-2008
• Recall Event ID: 48099
• 510(K)Number: K072504
• Product Classification: Medical linear accelerator - Product Code IYE
• Product: CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.
• Code Information: 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
• FEI Number: 1000123585
• Recalling Firm/ Manufacturer: Accuray Inc; 1310 Chesapeake Ter; Sunnyvale CA 94089-1100
• For Additional Information Contact: 408-716-4600
• Manufacturer 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: 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 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = IYE