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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Accuray Incorporated: Radixact System Upper Roller Bracket Recalled Due to Injury Risk

Agency Publication Date: August 31, 2023
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Summary

Accuray Incorporated has recalled 82 upper roller brackets used in the Gen2 gantry enclosure of Radixact Treatment Delivery Systems. This recall was initiated because the bracket may not provide enough clearance for service personnel to safely use a jib crane when moving heavy components during maintenance. If you use this system for medical treatments, please contact the manufacturer to ensure your service protocols are updated. No injuries have been reported at this time, and the issue primarily affects technical staff performing system repairs.

Risk

The lack of physical clearance prevents service personnel from using standard lifting equipment (a jib crane) safely. This creates a risk of mechanical failure or improper handling of heavy gantry components during servicing, which could lead to physical impact or crush injuries for service technicians.

What You Should Do

  1. Identify your Radixact Treatment Delivery System by checking the UDI-DI number 00811376030009 and the specific serial numbers provided in the recall documentation.
  2. Verify if your system's upper roller bracket matches part number 1088370 and one of the following serial numbers: 4010505 through 4010511, 4010513, 4010515 through 4010519, 4010521 through 4010533, 4010536 through 4010539, 4010541 through 4010546, 4010548 through 4010571, 4010573, 4010574, 4010577, 4010579, 4010582 through 4010590, 4010592, 4010593, 4010594, 4010596, 4010599, 4010600, 4010601, 4010607, or 4010609.
  3. Immediately notify your facility's biomedical engineering or maintenance department to ensure service personnel are aware of the clearance issue before any gantry maintenance is performed.
  4. Contact Accuray Incorporated at their Madison, Wisconsin facility (1240 Deming Way) or through your established service representative to schedule an inspection or receive updated service instructions.
  5. Contact your healthcare provider or the manufacturer for further instructions regarding system uptime and any potential impact on treatment schedules.
  6. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer visit and potential service adjustment

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Upper roller bracket (part number 1088370) for Gen2 gantry enclosure
Model / REF:
1088370
Radixact Treatment Delivery System
UPC Codes:
00811376030009
Lot Numbers (82):
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92772
Status: Resolved
Manufacturer: Accuray Incorporated
Sold By: Accuray Incorporated; Government distribution
Manufactured In: United States
Units Affected: 82
Distributed To: California, Georgia, Illinois, Louisiana, New Jersey, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.