The product affected by this notice is sold under the recall
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected…
Why was The product affected by this notice is sold under the recalled?
This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).
- Product
- The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 15 units
- Distribution
- Worldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
- Recall date
- September 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)