TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. Intended
FDA device recall Z-2115-2010 · posted 2010-08-02 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.
- Action taken
- Consignees were sent on 2/22/10 a TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated Monday, February 22, 2010. The letter was addressed to TomoTherapy Customer and identified the the affected product, and included a description of the Issue, Product Affected, Recommendation Actions and Resolution. The issue will be remedied by software versions 4.0.2 and later. Questions should be directed towards TomoTherapy Customer Interaction Center by e-mail or telephone.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 7
- Distribution
- Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.
- Date initiated
- 2010-02-22
- Date posted
- 2010-08-02
- Date terminated
- 2011-02-10
- 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 |