—#178204

Product

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.

FDA product code: NZT — Dosimeter, Ionizing Radiation, Implanted
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K182395
Affected lot / code info: Lot Numbers: 118881, 118929, 119750 UDI:00851546007714

Why it was recalled

May result in readings outside of the expected accuracy range.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

Distribution pattern: US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.

Timeline

Recall initiated: 2019-11-19
Terminated: 2020-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178204. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.