Date Initiated by Firm |
November 17, 2017 |
Create Date |
December 26, 2017 |
Recall Status1 |
Terminated 3 on July 25, 2021 |
Recall Number |
Z-0289-2018 |
Recall Event ID |
78686 |
510(K)Number |
K121934
|
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product |
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.
|
Code Information |
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 |
Recalling Firm/ Manufacturer |
Accuray Incorporated 1240 Deming Way Madison WI 53717-1954
|
For Additional Information Contact |
608-824-2800
|
Manufacturer Reason for Recall |
Uncontrolled couch Z-axis movement (descent)
|
FDA Determined Cause 2 |
Software design |
Action |
Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken.
The letter stated the following:
"Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series
software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem."
For questions contact Accuray Customer Support by phoning the regional support lines. |
Quantity in Commerce |
87 units |
Distribution |
Worldwide Distribution |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = ACCURAY INCORPORATED
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