The Recall Desk
HighFDA (Devices)·Z-0784-2021·Announced 2021-01-13

Accuray TomoTherapy System Recalled for MLC Tickling Error

Accuray is recalling seven TomoTherapy Treatment Systems because an MLC tickling error may cause the delivered radiation dose to rotate from the planned dose.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a defect could lead to incorrect radiation delivery, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Accuray Incorporated is recalling seven units of the TomoTherapy Treatment System. This integrated system is used for planning and delivering radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing radiation to healthy tissue.

The recall is due to an "MLC tickle error" which may result in the delivered dose effectively rotating from the planned dose. The affected units are distributed worldwide, including in the United States (CA, FL, IL, ND, NJ, OK, UT) and in Australia, China, Italy, Switzerland, and the United Arab Emirates.

The affected serial numbers are 110210, 110319, 110340, 110366, 110383, 110418, and 110468. The product codes are H-0000-0003, 104430, and 1018284, and the system version is 5.1.5. Users should contact Accuray Incorporated for further instructions regarding the recall.

The recalled product

Product
TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital h
Manufacturer
Accuray Incorporated
Category
Medical Device — Radiation Therapy System
Hazard
Affected units
7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Product Codes: H-0000-0003
  • 104430
  • 1018284. System Version 5.1.5. Serial Numbers: 110210
  • 110319
  • 110340
  • 110366
  • 110383
  • 110418
  • 110468

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Accuray Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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