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TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is int...

FDA Device Recall #Z-0287-2018 — Class II — November 17, 2017

Recall Summary

Recall Number Z-0287-2018
Classification Class II — Moderate risk
Date Initiated November 17, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Accuray Incorporated
Location Madison, WI
Product Type Devices
Quantity 118 units

Product Description

TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he 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 tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

Reason for Recall

Uncontrolled couch Z-axis movement (descent)

Distribution Pattern

Worldwide Distribution

Lot / Code Information

Serial Numbers: 110081 110100 110158 110180 110185 110194 110197 110208 110214 110228 110265 110266 110268 110286 110300 110311 110315 110332 110333 110347 110350 110354 110355 110357 110363 110368 110376 110378 110379 110380 110381 110385 110386 110387 110388 110390 110391 110392 110394 110396 110397 110401 110402 110405 110406 110407 110409 110412 110413 110414 110415 110419 110420 110422 110425 110426 110427 110430 110431 110434 110436 110437 110441 110442 110444 110445 110446 110447 110448 110451 110453 110454 110455 110458 110460 110464 110465 110466 110467 110469 110471 110472 110480 110482 110501 110504 110506 110511 110512 110517 110527 110528 110531 110532 110534 110539 110540 110541 110544 110545 110546 110547 110548 110549 110553 110555 110558 110563 110566 110569 110574 110578 110579 110591 110594 110596 110597 110606

Other Recalls from Accuray Incorporated

Recall # Classification Product Date
Z-1023-2025 Class II CyberKnife Treatment Delivery System, REF 06600... Dec 23, 2024
Z-2489-2023 Class II Upper roller bracket (part number 1088370) for ... Aug 3, 2023
Z-1272-2021 Class II CyberKnife Treatment Delivery System - Product ... Feb 26, 2021
Z-0785-2021 Class II TomoTherapy Treatment Delivery System with iDMS... Dec 10, 2020
Z-0784-2021 Class II TomoTherapy Treatment System - Product Usage: u... Dec 10, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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