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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86993

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 10, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Accuray Incorporated

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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 healthy tissue.

Z-0784-2021
Recall number
Z-0784-2021
Initiated
December 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
Accuray Incorporated
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

Code information

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

Distribution pattern

Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates.

device · product 2 of 2

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 radiation to vital healthy tissue.

Z-0785-2021
Recall number
Z-0785-2021
Initiated
December 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
Accuray Incorporated
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

Code information

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 pattern

Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates.