FDA Device recall Z-0527-2018
Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Gener…
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Gener… by Angiodynamics, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0527-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-05 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Angiodynamics |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Lots: 15310414, 15320417, 15340425, 15360433, 15370437, 15380441, 15390445, 15400451, 15470470, 15480472, 16050496, 160…Lots: 15310414, 15320417, 15340425, 15360433, 15370437, 15380441, 15390445, 15400451, 15470470, 15480472, 16050496, 16070501, 16130515, 16160525, 16190536, 16250558, 16320574, 16330579, 16420606, 16440612, 16460620, 16480630, 16500637, 17010646, 17030654, 17040659, 17070667, 17090672. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0527-2018%22
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