SharePlan 1.1 recall
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name…
Why was SharePlan 1.1 recalled?
This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not 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 delivered treatment. The behavior appears, when importing RFA-files (.asc)
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?
version 1.2.1 (build number 1.3.1.10).
- Product
- SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 20 units
- Distribution
- Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.
- Recall date
- October 3, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)