MICRO-PSD Electron, Catalog Number: PSD-EE5N - 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.
Recall
- Recall Number
- Z-0711-2020
- Event Number
- 84382
- Firm
- Angiodynamics, Inc.
- FEI Number
- 1319211
- Product Code
- NZT
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- November 19, 2019
- Terminated
- October 26, 2020
- Address
- 603 Queensbury Ave, Queensbury, NY, 12804-7619
Description
MICRO-PSD Electron, Catalog Number: PSD-EE5N - 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.
May result in readings outside of the expected accuracy range.
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.
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
36 units