HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART System is intended to be used as an int
FDA device recall Z-3108-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- As a result of an internal review, TomoTherapy has identified an issue with HiArt versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention. During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to ROIs and dose. When the anomaly occu
- Action taken
- TomoTherapy sent a "Urgent Medical Device Correction" letter dated July 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This issue will be remedied with HiArt software version 4.1 and HD software version 1.1 and later. If you have any questions, please contact the TomoTherapy Technical Solutions Center by e-mail "support@tomotherapy.com" . Please refer to the letter for what phone number you should call depending on where you are.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 346
- Distribution
- Worldwide Distribution-- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR
- Date initiated
- 2011-07-13
- Date posted
- 2011-08-31
- Date terminated
- 2014-03-18
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO HI-ART TREATMENT SYSTEM (K082005) | Tomotherapy Incorporated | 2008-08-25 |