| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00759-1 |
| Product Name/Description |
Accu2ipMTA Applicator
Product Codes: 900-600; 900-601; 900-602
Multiple Lot Numbers
ARTG Number: 174514 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
The supplier AngioDynamics has identified that the Accu2i pMTA Applicator has the potential to not function as expected during use. The desired microwave energy will not be delivered due to coolant ingress in an electrical connection, this condition results in an error code “High Reflective Power” displayed on the microwave generator. Please note that not all “High Reflective Power” error codes are a result of this failure mode, as this error code results from any instance where microwave energy is not efficiently transmitted to the tissue.
Although the specific failure mode of the applicator not delivering the desired microwave energy would not result in any direct harm to the patient; the inserted applicator will need to be removed and replaced in order to continue the procedure. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to inspect stocks, quarantine all affected units and complete the supplied Facsimile Reply Form to advise as to whether or not you still have stocks of the goods relevant to this recall.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9413 6204 - Getz Healthcare |