Z-0709-2020 Class II Terminated
FDA device recall Z-0709-2020 was initiated by Angiodynamics, Inc. on November 19, 2019 and is designated Class II. Reason for recall: May result in readings outside of the expected accuracy range. The recall status is terminated (terminated October 26, 2020). Affected quantity: 160 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- November 19, 2019
- Termination Date
- October 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160 units
Product Description
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 Pattern
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
Code Information
Lot Numbers: 114290, 114935 UDI 00851546007066