# FDA recall Z-0709-2020

> **Angiodynamics, Inc.** · Class II · device recall initiated 2019-11-19.

## Product

OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL  BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.

## Reason for recall

May result in readings outside of the expected accuracy range.

## Distribution

US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.

## Key facts

- **Recall number:** Z-0709-2020
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-19
- **Report date:** 2019-12-25
- **Termination date:** 2020-10-26

- **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-0709-2020

## Citation

> AI Analytics. FDA recall Z-0709-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0709-2020. Source: US FDA. Licensed CC0.

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