The Recall Desk
SevereFDA (Devices)·Z-0785-2021·Announced 2021-01-13

Accuray Recalls TomoTherapy Systems Due to Potential Radiation Dose Rotation Error

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device where a dosing error could lead to significant injury, fitting the rubric criteria for a Severe recall (score 4) involving significant injury reports or high-risk device defects.

Plain-English summary

Accuray Incorporated is recalling eight units of the TomoTherapy Treatment Delivery System with iDMS. The recall is due to a potential "MLC tickle error" that may result in the delivered dose effectively rotating from the planned dose. This system is used for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues.

The affected units are distributed worldwide, including in the United States (specifically in CA, FL, IL, ND, NJ, OK, and UT) and in Australia, China, Italy, Switzerland, and the United Arab Emirates. The specific serial numbers for the recalled units are 110105, 110219, 110221, 110267, 110284, 110290, 110308, and 110368. The affected system version is 1.2 (also referred to as 5.6.2).

Hospitals and clinics using these systems should contact Accuray Incorporated for instructions on how to address the issue. Patients who have received treatment on these specific units should consult their healthcare providers to discuss their treatment history.

The recalled product

Product
TomoTherapy Treatment Delivery System with iDMS - 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 r
Manufacturer
Accuray Incorporated
Category
Medical Device — Radiation Therapy Equipment
Hazard
Affected units
8

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 (11)

  • Product Codes: 104430
  • 1018286
  • H-0000-0003
  • 1018283. System Version: 1.2 (also referred to as 5.6.2). Serial Numbers: 110105
  • 110219
  • 110221
  • 110267
  • 110284
  • 110290
  • 110308
  • 110368

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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