Devices

Device Recall TomoHD(R) System

Model / Serial
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
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
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.
Manufacturer
Accuray Incorporated
1 Event
- Recall of Device Recall TomoHD(R) System

Manufacturer

Accuray Incorporated

Manufacturer Address
Accuray Incorporated, 1240 Deming Way, Madison WI 53717-1954
Manufacturer Parent Company (2017)
Accuray Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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