TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planni
FDA device recall Z-0628-2009 · posted 2009-01-22 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the "Superuser" and "Field Service engine
- Action taken
- A TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated October 17, 2008 was sent to all consignees. The letter addressed the Issue, Product Affected, Recommended Actions and Resolution. Please direct questions to the TomoTherapy, Inc. Customer Care Center by email (www.support@tomotherapy.com) or by telephone, North America: 1-866-368- 4807 and all other locations: 1-608-824-2900 or 32-2-400-44-44.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 215
- Distribution
- Worldwide Distribution --- USA including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NM, NY, OH,OK , OR, PR, PA, SC, SD, TN, TX, VA, WA, WI, W
- Date initiated
- 2008-10-14
- Date posted
- 2009-01-22
- Date terminated
- 2011-02-10
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: HI-ART SYSTEM (K060912) | Tomotherapy Incorporated | 2006-04-19 |