ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning and precise delivery of radiatio
FDA device recall Z-0814-2011 · posted 2010-12-27 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure.
- Action taken
- Consignees were sent a TomoTherapy "Urgent Field Safety Notice" dated November 8, 2010. The letter addressed to TomoTherapy Customers described the Issue, Product Affected, Recommended Action and Resolution. Customers are to contact the TomoTherapy Customer Interaction Center for further instruction and assistance in generating a completion procedure, if they experience the issue. Questions should be directed towards the TomoTherapy Customer Interaction Center via email or telephone.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 40 (21US; 19 OUS)
- Distribution
- Worldwide Distribution -- USA, including the states of AZ, CO, IL, KS, MI, MO, NV, NY, ND, OH, OK PA, UT, and VA and countries of MALAYSIA, SWITZERLAND, KOREA, ITALY, SPAIN, CANDA, TAIWAN, JAPAN, BELG
- Date initiated
- 2010-11-08
- Date posted
- 2010-12-27
- Date terminated
- 2012-02-04
- Location
- Madison, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO HI-ART TREATMENT SYSTEM (K082005) | Tomotherapy Incorporated | 2008-08-25 |