| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00446-1 |
| Product Name/Description |
Surface Applicator Set with Leipzig-style Cone
(indicated for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy)
IFU version: Dose Characterization GM11010080, 2012-09-06
ARTG Number: 126867 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
The dosimetry data provided in the Leipzig-style Surface Applicator's IFU was derived by performing Monte Carlo simulations. Subsequent simulations were performed to refine the data, but this refined data was not published in an IFU update. The most significant discrepancy is that 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 independent confirmation of the dose could result in an administration of dose greater than intended. This failure mode is not easily recognised by the user. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are recommended the following action:
· Users should CEASE USE of the published dose rate in the Surface Applicator Set with Leipzig-style Cone, GM11010080 IFU: Dose Characterization GM11010080 2012-09-06
· Users may use the Acuros BV to calculate dose rates and dose distributions of the surface applicators.
· Users may use Thermoluminescent Dosimeters (TLDs) to obtain dose rates & dose distributions of the surface applicators.
· Users may measure the surface applicator dosimetry using methods recommended in the following publication: Fulkerson RK, Micka JA, DeWerd LA. Dosimetric characterization and output verification for conical brachytherapy surface applicators. Part II. High dose rate 192lr sources. Medical Physics. 2014;41(2):022104. doi: 10.1118/ 1.4862506.
Varian is continuing its investigation and will update the IFU with corrected values as soon as possible. Varian will distribute updated Leipzig-style Surface Applicator's IFU to all affected users upon release. This action has been closed-out on 17/08/2016. |
| Contact Information |
02 9485 0100 - Varian Medical Systems |