Device product
Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, 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.
Z-0531-2018
Product summary
- Event
- Event 77631
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,353 units in total
- Official record key
device-enforcement:Z-0531-2018
Official wording
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.
Code information: Lots: 15330420, 15370436, 15390448, 15430457, 15450464, 15480474, 15490479, 15520485, 16030491, 16140518, 16160527, 16180533, 16300570, 16320576, 16350584, 16440615, 16460622, 16480628, 16500640, 16510643, 17010648, 17030656.
Distribution pattern: Worldwide distribution - US Nationwide
Derived failure modes
-
Unknown
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.