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U.S. Department of Health and Human Services

Class 2 Device Recall ORAtrac System

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  Class 2 Device Recall ORAtrac System see related information
Date Initiated by Firm November 19, 2019
Create Date December 19, 2019
Recall Status1 Terminated 3 on October 26, 2020
Recall Number Z-0713-2020
Recall Event ID 84382
510(K)Number K182395  
Product Classification Dosimeter, ionizing radiation, implanted - Product Code NZT
Product MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - 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.
Code Information Lot Numbers: 106020, 106030, 119400 UDI: 00851546007141
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information Contact SAME
518-798-1215
Manufacturer Reason
for Recall		 May result in readings outside of the expected accuracy range.
FDA Determined
Cause 2		 Under Investigation by firm
Action AngioDynamics issued Urgent Medical Device Correction Letter on November 19, 2019, via Federal Express. The letter states reason for recall , health risk and action to take: Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate and return all affected devices to AngioDynamics, Inc. Consignees are directed to complete and return the Reply Verification Tracking Form, provided in the recall notification. cCall AngioDynamics Customer Service at 1-800- 772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time) to obtain an RMA for your returned product.
Quantity in Commerce 48 units
Distribution US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NZT and Original Applicant = RadialDyne, LLC
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