TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise
FDA device recall Z-1649-2011 · posted 2011-03-14 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- It was determined that the Treatment Planning Station (TPS) can potentially under dose.
- Action taken
- Consignees were sent a TomoTherapy "Field Safety Notice Medical Device Correction" letter dated January 26, 2011. The letter was addressed to "TomoTherapy Customer". The letter described the Planning Issue, Related DQA Consideration, Graphical Presentation of Results, Product Affected, Recommended Action and Resolution. The letter suggests to use the information presented in order to avoid creating plans with an increased potential for discrepancies in planned vs. delivered dose. Specifically include measurements for small, off-axis targets that could be susceptible to the effects of this issue. DQA dose measurements should be performed at each unique full fraction dose that will be used for patient treatment, without using DQA scaling. If Customers have any questions they are to contact TomoTherapy Interaction Center by email or phone.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 326
- Distribution
- Worldwide Distribution -- US, including 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, NV, NJ, NM, NY ,NC, ND,OH, OK OR, PA, PR, SC, SD, TN,
- Date initiated
- 2011-01-26
- Date posted
- 2011-03-14
- Date terminated
- 2014-03-18
- Location
- Madison, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO HI-ART TREATMENT SYSTEM (K082005) | Tomotherapy Incorporated | 2008-08-25 |