Recall Z-0527-2018 ยท NEY System, Ablation, Microwave And Accessories
Angiodynamics, Inc.
Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
| Date | Jun 5, 2017 |
| Status | Terminated |
| Reason | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator. |
| Root cause | Under Investigation by firm |
| Action | URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters and Response Forms (dated June 5, 2107) were sent to consignees via FedEx on June 5, 2017. The letter identified the affected product, problem and actions to be taken. |
| Quantity | 14,353 units in total |
| Distribution | Worldwide distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K094021 | ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I Microsulis Medical Limited, Aug 6, 2010 |