Devices

Device Recall TomoHDA(R) System

Model / Serial
Serial Numbers: 110033 110137 110155 110206 110221 110290 110318 110348 110353 110360 110364 110384 110408 110410 110411 110452 110457 110463 110473 110475 110476 110477 110478 110479 110481 110483 110484 110485 110486 110487 110488 110489 110490 110492 110493 110496 110498 110500 110502 110513 110514 110515 110516 110518 110520 110521 110523 110524 110526 110529 110530 110535 110538 110542 110543 110550 110551 110557 110559 110560 110561 110564 110567 110571 110572 110575 110580 110582 110583 110584 110585 110586 110587 110588 110593 110598 110599 110600 110603 110604 110605 110609 110610 110612 110613 110614 110616
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
TomoHDA(R) System, Model Number 1018286 || 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 TomoHDA(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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