Print version of this report
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 Getz Healthcare Pty Ltd
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.
Contact Information 02 9413 6204 - Getz Healthcare