TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The T
FDA device recall Z-2072-2010 · posted 2010-07-22 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect dose statistics.
- Action taken
- Consignees were sent on 6/23/10 a TomoTherapy "Urgent Field Safety Notice Medical device Correction" letter dated June 22, 1010. The letter addressed the Issue, Product Affected, Recommended Action and Resolution. Prior to generating a draft or final Plan Report for a given plan, the plan must be closed and reopened at least once. This issue will be remedied by Hi-Art software version 4.0.3, scheduled for release in late 2010. Customers with questions were provided with a contact in the letter at the TomoTherapy Customer Interaction Center. The firm can be contacted at 608-824-2800.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 29
- Distribution
- CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE.
- Date initiated
- 2010-06-23
- Date posted
- 2010-07-22
- 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 |