Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the p
FDA device recall Z-2219-2010 · posted 2010-08-12 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs allow for images to be moved during planning. During registration when roll is applied on moved images, the Operator Station incorrectly rolls the image about
- Action taken
- Consignee was sent a TomoTherapy "Urgent Medical device Correction Field Safety Notice' dated December 01, 2009. The letter described the Issue, Product Affected, Recommended Action and Resolution.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 1
- Distribution
- VA
- Date initiated
- 2009-12-01
- Date posted
- 2010-08-12
- Date terminated
- 2011-12-17
- 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 |