Surface Applicator Set with Leipzig-style Cone. recall
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Why was Surface Applicator Set with Leipzig-style Cone. recalled?
Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat
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?
JAQ
- Product
- Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
- Recalling firm
- Varian Medical Systems Inc
- Quantity
- 46
- Distribution
- Worldwide Distribution.
- Recall date
- July 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)