TomoHDA(R) System recall
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he…
Why was TomoHDA(R) System recalled?
Uncontrolled couch Z-axis movement (descent)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he…
- Recalling firm
- Accuray Incorporated
- Quantity
- 87 units
- Distribution
- Worldwide Distribution
- Recall date
- January 3, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)