TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Plan
FDA device recall Z-0339-2009 · posted 2009-01-05 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the DVH curve and the Dose Statistics for the small structures. This error can only happen if planning was performed using very small voxels
- Action taken
- Consignees were sent on 9/18/08 a "TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice" letter dated September 17, 2008. The letter described the issue, product affected, recommended actions and resolution. Questions may be directed to TomoTherapy Inc. Customer Service Center at 1-868-368-4807.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 165
- Distribution
- AK AL AR AZ CA CO CT DC FL HI IA IL IN KY LA MA MD MI MN MO NE NJ NM NV NY OH OK OR PA PR SC SD TN TX VA WA WI and WY Belgium Canada Switzerland Germany Spain France Great Britain India Italy Japan Ko
- Date initiated
- 2008-09-18
- Date posted
- 2009-01-05
- Date terminated
- 2011-04-19
- Location
- Madison, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: HI-ART SYSTEM (K060912) | Tomotherapy Incorporated | 2006-04-19 |