Recall Z-0712-2020 ยท NZT Dosimeter, Ionizing Radiation, Implanted
Angiodynamics, Inc.
MICRO-PSD HDR, Catalog Number: PSD-HB5N - 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.
| Date | Nov 19, 2019 |
| Status | Terminated |
| Reason | May result in readings outside of the expected accuracy range. |
| Root cause | 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- 772-64 |
| Quantity | 60 units |
| Distribution | US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182395 | OARtrac System Radialdyne, LLC, Mar 22, 2019 |