FDA recall Z-0709-2020

Angiodynamics, Inc. · Class II · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0709-2020