# FDA recall Z-0529-2018

> **Angiodynamics, Inc.** · Class II · device recall initiated 2017-06-05.

## Product

Accu2i pMTA  Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, 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 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.

## Distribution

Worldwide distribution - US Nationwide

## Key facts

- **Recall number:** Z-0529-2018
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-05
- **Report date:** 2018-02-14
- **Termination date:** 2018-09-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Queensbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0529-2018

## Citation

> AI Analytics. FDA recall Z-0529-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0529-2018. Source: US FDA. Licensed CC0.

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