Home / Recalls / Accuray Incorporated / Z-1696-2019

Z-1696-2019 Class II Terminated

Recalled by Accuray Incorporated — Madison, WI

FDA device recall Z-1696-2019 was initiated by Accuray Incorporated on April 10, 2018 and is designated Class II. Reason for recall: There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this o… The recall status is terminated (terminated April 1, 2021). Affected quantity: 68 units.

Recall Details

Product Type
Devices
Report Date
June 12, 2019
Initiation Date
April 10, 2018
Termination Date
April 1, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
68 units

Product Description

CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS

Reason for Recall

There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.

Distribution Pattern

US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand

Code Information

a) 0660000: CyberKnife Treatment Delivery System Serial Numbers: C0434, C0436, C0437, C0438, C0440, C0441, C0443, C0444, C0445, C0446, C0447, C0448, C0449, C0450, C0453, C0454, C0456, C0457, C0458, C0460, C0464, C0465, C0466, C0472, C0475 b) 053101-010: CyberKnife M6 FI Treatment Delivery System Serial Numbers: C0334, C0381 c) 053201-010: CyberKnife M6 FM Treatment Delivery System Serial Numbers: C0363 d) 053301-010: CyberKnife M6 FIM Treatment Delivery System Serial Numbers: C0337, C0343, C0349, C0352, C0358, C0370, C0371, C0378, C0384, C0387, C0389, C0390, C0391, C0393, C0409, C0424, C0426, C0427, C0428, C0433, C0439 e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System Serial Numbers: C0330, C0332, C0342, C0344, C0345, C0348, C0359, C0360, C0364, C0367, C0372, C0394, C0398, C0400, C0402, C0404, C0415, C0419 f) 053501-010: CyberKnife Matrix Tier F TDS Serial Numbers: C0396

Other recalls by Accuray Incorporated

  • Z-2644-2026 Class II — Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator (June 16, 2026)
  • Z-2640-2026 Class II — Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator (June 16, 2026)
  • 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-0784-2021 Class II — TomoTherapy Treatment System - Product Usage: used as an integrated system for t (December 10, 2020)
  • Z-0785-2021 Class II — TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an inte (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-1697-2019 Class II — CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radi (April 10, 2018)

FDA data resources