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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 99083

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 16, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

1 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 1

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

Z-2644-2026
Recall number
Z-2644-2026
Initiated
June 16, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Accuray Incorporated
Quantity
292 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.

Code information

ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.

Distribution pattern

Worldwide - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

Field note

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