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Use caution Medical device recall · FDA · Published August 3, 2023

Accuray Radixact System Upper Roller Bracket Recall: Service Risk

Accuray recalls specific Radixact Treatment Delivery System upper roller brackets (part 1088370) for potential service safety hazards during equipment maintenance.

🇺🇸 FDA recall #Z-2489-2023Medical deviceAccuray ›
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Recalling firmAccuray Incorporated1240 Deming Way · Madison, WI 53717-1954
✎ GovInfoNow plain-language explainer

Accuray is recalling certain upper roller brackets for the Radixact Treatment Delivery System. These parts may not provide enough clearance for service personnel using jib cranes, risking injury during equipment maintenance. Read more at govinfonow.com/recall/57547-accuray-radixact-system-upper-roller-bracket-recall-service-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57547-accuray-radixact-system-upper-roller-bracket-recall-service-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2489-2023

Cite this page

“Accuray Radixact System Upper Roller Bracket Recall: Service Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57547-accuray-radixact-system-upper-roller-bracket-recall-service-risk. Based on FDA recall #Z-2489-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2489-2023%22&limit=1).

The FDA announced on August 3, 2023, that Accuray Incorporated is recalling the upper roller bracket (part number 1088370) for the Gen2 gantry enclosure of the Radixact Treatment Delivery System. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

  • Brand: Accuray
  • Product: Upper roller bracket for the Gen2 gantry enclosure for the Radixact Treatment Delivery System
  • Part number: 1088370
  • UDI-DI: 00811376030009
  • Serial numbers: 4010505, 4010506, 4010507, 4010508, 4010509, 4010510, 4010511, 4010513, 4010515, 4010516, 4010517, 4010518, 4010519, 4010521, 4010522, 4010523, 4010524, 4010525, 4010526, 4010527, 4010528, 4010529, 4010530, 4010531, 4010532, 4010533, 4010536, 4010537, 4010538, 4010539, 4010541, 4010542, 4010543, 4010544, 4010545, 4010546, 4010548, 4010549, 4010550, 4010551, 4010552, 4010553, 4010554, 4010555, 4010556, 4010557, 4010558, 4010559, 4010560, 4010561, 4010562, 4010563, 4010564, 4010565, 4010566, 4010567, 4010568, 4010569, 4010570, 4010571, 4010573, 4010574, 4010577, 4010579, 4010582, 4010583, 4010584, 4010585, 4010586, 4010587, 4010588, 4010589, 4010590, 4010592, 4010593, 4010594, 4010596, 4010599, 4010607, 4010600, 4010601, and 4010609
  • Units affected: 82

The hazard

According to the FDA, the upper roller bracket may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system. This condition could result in possible injury to the service personnel.

Context

GovInfoNow's records show Accuray Incorporated has 9 other recalls on record since November 17, 2017. Other recent recalls of similar products include Molift 4-Point Sling Bars Recall: Deformation Risk During Use (November 17, 2025), Philips Spectral CT 7500 on Rails Recall: Unsecured Rotor Risk (January 7, 2026), and Canon Alphenix X-ray Systems Recall: Loose Fixing Screws Risk Equipment Failure (August 4, 2026).

How to tell if you have this one

Check if your Radixact Treatment Delivery System has the upper roller bracket with part number 1088370. Look for serial numbers in the list provided: 4010505 through 4010609 (excluding some numbers).

  • Brand
    Accuray
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Your Equipment

    Identify if your Radixact Treatment Delivery System includes the recalled upper roller bracket with part number 1088370 and the listed serial numbers.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 11 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, GA, IL, LA, NJ, OR, PA, SC, SD, TX, and WA. There was government distribution and no military distribution. The countries of Australia, Belgium, Canada, Colombia, France, India,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia, Illinois, Louisiana, New Jersey, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Washington.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Aug 3, 202312. FDA classified it Class II: Aug 31, 202323. Published in FDA’s Enforcement Report: Sep 6, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2489-2023 (August 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2489-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA