Recall Z-0530-2018
Angiodynamics, Inc. · initiated June 5, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, 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.
Codes / lots: Lots: 15330421, 15340426, 15370438, 15390447, 15400452, 15430458, 15440462, 15450465, 15480475, 15500482, 15520486, 16060497, 16100507, 16130516, 16140519, 16160526, 16180532, 16190537, 16240553, 16330580, 16350583, 16380594, 16410601, 16420607, 16430608, 16440616, 16460623, 16480629, 16500639, 17020652, 17090671, 17140694.
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0530-2018
- Initiated
- June 5, 2017
- Terminated
- September 11, 2018
- Product code
- NEY – System, Ablation, Microwave And Accessories
- Quantity
- 14,353 units in total
- Distribution
- Worldwide distribution - US Nationwide
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0526-2018 Class II | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0527-2018 Class II | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0528-2018 Class II | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN)…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0529-2018 Class II | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN)…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0531-2018 Class II | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN)…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |