Home / Recalls / Accuray Incorporated / Z-0734-2017

Z-0734-2017 Class II Terminated

Recalled by Accuray Incorporated — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
December 21, 2016
Initiation Date
November 22, 2016
Termination Date
May 22, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 affected devices

Product Description

CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Reason for Recall

Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife¿ Systems with software version 1 0.6.

Distribution Pattern

Worldwide Distribution - US Distribution to the states of : PA, WA, MT, NY, SC, CA, MN, AK, NJ, FL, KY, WI., and to the countries of : Bulgaria, Canada, France, Germany, India, Japan, Luxembourg, Netherlands, Portugal, Switzerland and Turkey

Code Information

Catalog/Part Number: 54000 manufacturing or serial number of UDI: M658053301 0; Serial numbers: C0330 C0334 C0336 C0338 C0342 C0344 C0348 C0349 C0351 C0358 C0359 C0360 C0361 C0363 C0364 C0366 C0367 C0370 C0372 C0376 C0387 C0389 C0390 C0391 C0393 C0394 C0395 C0396 C0397 C0398 C0400 C0402 C0404 C0406 C0407 C0408 C0409 C0410 C0413 C0414

Other recalls by Accuray Incorporated

  • Z-1023-2025 Class II — CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may b (December 23, 2024)
  • Z-2489-2023 Class II — Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the (August 3, 2023)
  • Z-1272-2021 Class II — CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided (February 26, 2021)
  • Z-0785-2021 Class II — TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an inte (December 10, 2020)
  • Z-0784-2021 Class II — TomoTherapy Treatment System - Product Usage: used as an integrated system for t (December 10, 2020)
  • Z-0408-2019 Class II — CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicate (September 26, 2018)
  • Z-3211-2018 Class II — Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is use (August 31, 2018)
  • Z-1696-2019 Class II — CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System (April 10, 2018)
  • Z-1697-2019 Class II — CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radi (April 10, 2018)
  • Z-0289-2018 Class II — TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treat (November 17, 2017)