Accuray Incorporated: Medical Device Recall in 2016 - (Recall #: Z-0734-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 22, 2016

Date Posted: December 21, 2016

Recall Number: Z-0734-2017

Event ID: 75863

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.

Status: Terminated

Product Quantity: 40 affected devices

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

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

Voluntary or Mandated:

Voluntary: Firm initiated